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The purpose of this study is to characterize the safety and efficacy in patients with generalized anxiety disorder after short- (3 months) and long-term (6 months) use of Pregabalin (Lyrica).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
| |
| 3 | Experimental |
| |
| 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Pregabalin 150-300 mg given twice a day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Baseline, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9) |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Baseline, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9) |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Baseline, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Baseline, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Rebound Anxiety for Cohort 1 (Less Than 3-Month Last Visit) | Rebound anxiety was defined as a rapid return of the participant's original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value. | 2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9) |
| Measure | Description | Time Frame |
|---|---|---|
| Sheehan-Suicidality Tracking Scale (S-STS) Score | Sheehan-Suicidality Tracking Scale (S-STS): an 8-item prospective rating scale that tracked treatment-emergent suicidal ideation and behaviors. Items 1a, 2-6, 7a, and 8 were scored on a 5-point Likert scale (ranging from 0= not at all to 4=extremely). Items 1, 1b, and 7 required yes or no responses. Total score ranged from 0 to 35, higher score indicated higher suicidal tendency. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | La Plata | Buenos Aires | B1904ADM | Argentina | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24351233 | Derived | Kasper S, Iglesias-Garcia C, Schweizer E, Wilson J, DuBrava S, Prieto R, Pitman VW, Knapp L. Pregabalin long-term treatment and assessment of discontinuation in patients with generalized anxiety disorder. Int J Neuropsychopharmacol. 2014 May;17(5):685-95. doi: 10.1017/S1461145713001557. Epub 2013 Dec 19. |
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This study employed 3 treatments in Period 1 and 6 treatments in Period 2. Randomization occurred once, at the onset of Period 1.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin High Dose, Pregabalin High Dose | Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Optimization (Up to Week 12) |
|
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| Lorazepam | Drug | Lorazepam 3-4 mg given twice a day |
|
| Pregabalin | Drug | Pregabalin 450-600 mg given twice a day |
|
|
| Placebo | Drug | Placebo |
|
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. |
| Baseline, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. | Baseline, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) |
| Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9) |
| Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2 | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9) |
| Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) |
| Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2 | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) |
| Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) |
| Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2 | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) |
| Number of Participants With Rebound Anxiety for Cohort 2 (3-Month Last Visit) | Rebound anxiety was defined as a rapid return of the participant's original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value. | 2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) |
| Number of Participants With Rebound Anxiety for Cohort 3 (6-Month Last Visit) | Rebound anxiety was defined as a rapid return of the participant's original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value. | 2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) |
| Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 1 (Less Than 3-Month Last Visit) | DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2. | 2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9) |
| Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 2 (3-Month Last Visit) | DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2. | 2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) |
| Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 3 (6-Month Last Visit) | DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2. | 2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) |
| Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2 | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9) |
| Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2 | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) |
| Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2 | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Baseline, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24) |
| Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9) |
| Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) |
| Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Week 1, 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) |
| Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9) |
| Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. | Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) |
| Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24) |
| Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9) |
| Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. | Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) |
| Hamilton Anxiety Scale (HAM-A) Score for Cohort 3 (6-Month Last Visit) | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24) |
| Hamilton Anxiety Scale (HAM-A) Score for Period 1 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Baseline, Week 12 |
| Hamilton Anxiety Scale (HAM-A) Score for Period 2 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Baseline, Week 24 |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 12 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Baseline, Week 12 |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 24 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Baseline, Week 24 |
| Clinical Global Impression - Severity (CGI-S) Score for Period 1 | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. | Baseline, Week 12 |
| Clinical Global Impression - Severity (CGI-S) Score for Period 2 | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected | Baseline, Week 24 |
| Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12 | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. | Baseline, Week 12 |
| Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24 | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected | Baseline, Week 24 |
| Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 1 | CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. | Week 12 |
| Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 2 | CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. | Week 24 |
| Baseline up to Week 24 |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and Week 12, for period 1, and between Week 13 and Week 24, for period 2, that were absent before treatment or that worsened relative to pretreatment state. | Baseline up to Week 12 (period 1), Week 13 up to Week 24 (period 2) |
| Lanus |
| Prov. de Buenos Aires |
| B1824IBR |
| Argentina |
| Pfizer Investigational Site | Buenos Aires | C1115AAJ | Argentina |
| Pfizer Investigational Site | Buenos Aires | C1405BOA | Argentina |
| Pfizer Investigational Site | Buenos Aires | C1428AQK | Argentina |
| Pfizer Investigational Site | Vienna | A-1010 | Austria |
| Pfizer Investigational Site | Vienna | A-1090 | Austria |
| Pfizer Investigational Site | San José | 00000 | Costa Rica |
| Pfizer Investigational Site | San José | Costa Rica |
| Pfizer Investigational Site | Rijeka | 51000 | Croatia |
| Pfizer Investigational Site | Split | 21000 | Croatia |
| Pfizer Investigational Site | Zagreb | 10000 | Croatia |
| Pfizer Investigational Site | Brno | 602 00 | Czechia |
| Pfizer Investigational Site | České Budějovice | 370 87 | Czechia |
| Pfizer Investigational Site | Litoměřice | 412 01 | Czechia |
| Pfizer Investigational Site | Lnáře | 387 42 | Czechia |
| Pfizer Investigational Site | Mělník | 276 01 | Czechia |
| Pfizer Investigational Site | Prague | 120 00 | Czechia |
| Pfizer Investigational Site | Prague | 160 00 | Czechia |
| Pfizer Investigational Site | Praha 10- Strasnice | 10000 | Czechia |
| Pfizer Investigational Site | Strakonice | 386 01 | Czechia |
| Pfizer Investigational Site | Espoo | 02650 | Finland |
| Pfizer Investigational Site | HUS | 00029 | Finland |
| Pfizer Investigational Site | Joensuu | 80100 | Finland |
| Pfizer Investigational Site | Kuopio | 70110 | Finland |
| Pfizer Investigational Site | Seinäjoki | 60100 | Finland |
| Pfizer Investigational Site | Turku | 20100 | Finland |
| Pfizer Investigational Site | Athens | 11528 | Greece |
| Pfizer Investigational Site | Ellisbridge | Ahmedabad | 380 006 | India |
| Pfizer Investigational Site | Tirupati | Andhra Pradesh | 517 507 | India |
| Pfizer Investigational Site | Mangalore | Karnataka | 575001 | India |
| Pfizer Investigational Site | Pune | Maharashtra | 411 030 | India |
| Pfizer Investigational Site | Chennai | Tamil Nadu | 600 003 | India |
| Pfizer Investigational Site | Denpasar | Bali | Indonesia |
| Pfizer Investigational Site | Jakarta | Jakarta Selatan | Indonesia |
| Pfizer Investigational Site | Jakarta Selatan | Jakarta Special Capital Region | 10430 | Indonesia |
| Pfizer Investigational Site | Surabaya | Indonesia |
| Pfizer Investigational Site | Kaunas | 50185 | Lithuania |
| Pfizer Investigational Site | Kaunas | 50425 | Lithuania |
| Pfizer Investigational Site | Klaipėda | 94231 | Lithuania |
| Pfizer Investigational Site | Vilnius | 09112 | Lithuania |
| Pfizer Investigational Site | Acapulco de Juárez | Guerrero | 39670 | Mexico |
| Pfizer Investigational Site | Zapopan | Jalisco | 45170 | Mexico |
| Pfizer Investigational Site | Mexico City | 14269 | Mexico |
| Pfizer Investigational Site | Khotkovo, Moscow Region | 142601 | Russia |
| Pfizer Investigational Site | Moscow | 107076 | Russia |
| Pfizer Investigational Site | Moscow | 115522 | Russia |
| Pfizer Investigational Site | Moscow | 119021 | Russia |
| Pfizer Investigational Site | Moscow | 125367 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 192019 | Russia |
| Pfizer Investigational Site | Belgrade | 11000 | Serbia |
| Pfizer Investigational Site | Kragujevac | 34000 | Serbia |
| Pfizer Investigational Site | Ljubljana | Slovenia |
| Pfizer Investigational Site | Langreo | Principality of Asturias | 33900 | Spain |
| Pfizer Investigational Site | Zamora | 49021 | Spain |
| Pfizer Investigational Site | Istanbul | 34203 | Turkey (Türkiye) |
| Pfizer Investigational Site | Kocaeli | 41380 | Turkey (Türkiye) |
| FG001 | Pregabalin High Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| FG002 | Pregabalin Low Dose, Pregabalin Low Dose | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| FG003 | Pregabalin Low Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| FG004 | Lorazepam, Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| FG005 | Lorazepam, Placebo | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| COMPLETED |
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| NOT COMPLETED |
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|
| Fixed Dosing (Week 13 to Week 24) |
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| Treatment Discontinuation (Week 25) |
|
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| Follow-up (Week 26) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin High Dose, Pregabalin High Dose | Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| BG001 | Pregabalin High Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| BG002 | Pregabalin Low Dose, Pregabalin Low Dose | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| BG003 | Pregabalin Low Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| BG004 | Lorazepam, Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| BG005 | Lorazepam, Placebo | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included. n=participants evaluable at given time points for each group. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9) |
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| Primary | Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9) |
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| Primary | Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) |
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| Primary | Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) |
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| Primary | Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) |
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| Primary | Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. | Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) |
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| Primary | Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. 'n' = participants evaluable at given time points for each group respectively. | Posted | Mean | Standard Deviation | units on a scale | Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9) |
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| Primary | Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2 | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants evaluable for this measure. | Posted | Mean | Standard Deviation | units on a scale | Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9) |
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| Primary | Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | units on a scale | Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) |
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| Primary | Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2 | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | units on a scale | Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) |
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| Primary | Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | units on a scale | Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) |
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| Primary | Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2 | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | units on a scale | Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) |
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| Secondary | Number of Participants With Rebound Anxiety for Cohort 1 (Less Than 3-Month Last Visit) | Rebound anxiety was defined as a rapid return of the participant's original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value. | Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | participants | 2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9) |
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| Secondary | Number of Participants With Rebound Anxiety for Cohort 2 (3-Month Last Visit) | Rebound anxiety was defined as a rapid return of the participant's original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value. | Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | participants | 2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) |
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| Secondary | Number of Participants With Rebound Anxiety for Cohort 3 (6-Month Last Visit) | Rebound anxiety was defined as a rapid return of the participant's original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value. | Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | participants | 2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) |
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| Secondary | Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 1 (Less Than 3-Month Last Visit) | DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2. | Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. | Posted | Number | participants | 2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9) |
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| Secondary | Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 2 (3-Month Last Visit) | DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2. | Per-protocol analysis set. Cohort 1: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. | Posted | Number | participants | 2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) |
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| Secondary | Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 3 (6-Month Last Visit) | DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2. | Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. | Posted | Number | participants | 2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) |
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| Secondary | Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2 | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. 'n' = participants evaluable at given time points for each group respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9) |
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| Secondary | Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2 | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. 'n' = participants evaluable at given time points for each group respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) |
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| Secondary | Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2 | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included. N (Number of Participants Analyzed) = participants evaluable for this measure. 'n'=participants evaluable at given time points for each group respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24) |
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| Secondary | Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. 'n' = participants evaluable at given time points for each group respectively. | Posted | Mean | Standard Deviation | units on a scale | Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9) |
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| Secondary | Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. 'n' = participants evaluable at given time points for each group respectively. | Posted | Mean | Standard Deviation | units on a scale | Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) |
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| Secondary | Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included. N (Number of Participants Analyzed) = participants evaluable for this measure. 'n' = participants evaluable at given time points for each group respectively. | Posted | Mean | Standard Deviation | units on a scale | Week 1, 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) |
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| Secondary | Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. 'n' = participants evaluable at given time points for each group respectively. | Posted | Mean | Standard Deviation | units on a scale | Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9) |
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| Secondary | Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. | Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. 'n' = participants evaluable at given time points for each group respectively. | Posted | Mean | Standard Deviation | units on a scale | Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) |
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| Secondary | Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included. N(Number of Participants Analyzed) = participants evaluable for this measure. 'n' = participants evaluable at given time points for each group respectively. | Posted | Mean | Standard Deviation | units on a scale | Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24) |
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| Secondary | Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. 'n' = participants evaluable at given time points for each group respectively. | Posted | Mean | Standard Deviation | units on a scale | Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9) |
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| Secondary | Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. | Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. 'n' = participants evaluable at given time points for each group respectively. | Posted | Mean | Standard Deviation | units on a scale | Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) |
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| Secondary | Hamilton Anxiety Scale (HAM-A) Score for Cohort 3 (6-Month Last Visit) | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included. N (Number of Participants Analyzed) = participants evaluable for this measure. 'n' = participants evaluable at given time points for each group respectively. | Posted | Mean | Standard Deviation | units on a scale | Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24) |
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| Secondary | Hamilton Anxiety Scale (HAM-A) Score for Period 1 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Last observation carried forward (LOCF) method was used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
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| Secondary | Hamilton Anxiety Scale (HAM-A) Score for Period 2 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 24 |
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| Secondary | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 12 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 24 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. | Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Clinical Global Impression - Severity (CGI-S) Score for Period 1 | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. | Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Clinical Global Impression - Severity (CGI-S) Score for Period 2 | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected | Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12 | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. | Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. LOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24 | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected | Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 24 |
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| Secondary | Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 1 | CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. | Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 2 | CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. | Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Week 24 |
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| Other Pre-specified | Sheehan-Suicidality Tracking Scale (S-STS) Score | Sheehan-Suicidality Tracking Scale (S-STS): an 8-item prospective rating scale that tracked treatment-emergent suicidal ideation and behaviors. Items 1a, 2-6, 7a, and 8 were scored on a 5-point Likert scale (ranging from 0= not at all to 4=extremely). Items 1, 1b, and 7 required yes or no responses. Total score ranged from 0 to 35, higher score indicated higher suicidal tendency. | Data was not statistically summarized but was available in individual participant listings and mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) due to change in planned analysis. | Posted | Baseline up to Week 24 |
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| Other Pre-specified | Number of Participants With Treatment-Emergent Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and Week 12, for period 1, and between Week 13 and Week 24, for period 2, that were absent before treatment or that worsened relative to pretreatment state. | Safety analysis set: all randomized participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure during each specified period, for each group respectively. | Posted | Number | participants | Baseline up to Week 12 (period 1), Week 13 up to Week 24 (period 2) |
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin High Dose, Pregabalin High Dose | Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). | 2 | 154 | 110 | 154 | ||
| EG001 | Pregabalin High Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). | 0 | 52 | 40 | 52 | ||
| EG002 | Pregabalin Low Dose, Pregabalin Low Dose | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). | 5 | 154 | 108 | 154 | ||
| EG003 | Pregabalin Low Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). | 2 | 52 | 38 | 52 | ||
| EG004 | Lorazepam, Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). | 4 | 153 | 100 | 153 | ||
| EG005 | Lorazepam, Placebo | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). | 0 | 50 | 35 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Typhoid fever | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Generalised anxiety disorder | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Generalised anxiety disorder | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Tension | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D008140 | Lorazepam |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Other |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Adverse Event |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Other |
|
| 45 to 64 years |
|
| Greater than or equal to 65 years |
|
| Male |
|
|
Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. |
| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
|
|
Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. |
| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
|
|
Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. |
| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
|
|
| OG001 | Pregabalin High Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG002 | Pregabalin Low Dose, Pregabalin Low Dose | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG003 | Pregabalin Low Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG004 | Lorazepam, Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG005 | Lorazepam, Placebo | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
|
|
| OG001 | Pregabalin High Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG002 | Pregabalin Low Dose, Pregabalin Low Dose | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG003 | Pregabalin Low Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG004 | Lorazepam, Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG005 | Lorazepam, Placebo | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
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| OG001 | Pregabalin Low Dose | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. |
| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
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| Pregabalin Low Dose |
Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. |
| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
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| Pregabalin Low Dose |
Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. |
| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
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| Pregabalin Low Dose |
Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. |
| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
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| OG001 | Pregabalin High Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG002 | Pregabalin Low Dose, Pregabalin Low Dose | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG003 | Pregabalin Low Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG004 | Lorazepam, Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG005 | Lorazepam, Placebo | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
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| OG001 | Pregabalin High Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG002 | Pregabalin Low Dose, Pregabalin Low Dose | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG003 | Pregabalin Low Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG004 | Lorazepam, Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG005 | Lorazepam, Placebo | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
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Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. |
| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
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Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. |
| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
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| OG001 | Pregabalin High Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG002 | Pregabalin Low Dose, Pregabalin Low Dose | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG003 | Pregabalin Low Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG004 | Lorazepam, Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG005 | Lorazepam, Placebo | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
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| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
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| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
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| OG001 | Pregabalin High Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG002 | Pregabalin Low Dose, Pregabalin Low Dose | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG003 | Pregabalin Low Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG004 | Lorazepam, Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG005 | Lorazepam, Placebo | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
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| OG001 |
| Pregabalin Low Dose |
Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. |
| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
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| OG001 |
| Pregabalin Low Dose |
Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. |
| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
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| OG001 | Pregabalin High Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG002 | Pregabalin Low Dose, Pregabalin Low Dose | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG003 | Pregabalin Low Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG004 | Lorazepam, Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG005 | Lorazepam, Placebo | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
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| Pregabalin Low Dose |
Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. |
| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
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| Pregabalin Low Dose |
Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. |
| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
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| OG001 | Pregabalin High Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG002 | Pregabalin Low Dose, Pregabalin Low Dose | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG003 | Pregabalin Low Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG004 | Lorazepam, Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG005 | Lorazepam, Placebo | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
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| Pregabalin Low Dose |
Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. |
| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
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| Pregabalin Low Dose |
Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. |
| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
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| OG001 | Pregabalin High Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG002 | Pregabalin Low Dose, Pregabalin Low Dose | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG003 | Pregabalin Low Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG004 | Lorazepam, Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG005 | Lorazepam, Placebo | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
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Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. |
| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
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Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. |
| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
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| OG001 | Pregabalin High Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG002 | Pregabalin Low Dose, Pregabalin Low Dose | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG003 | Pregabalin Low Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG004 | Lorazepam, Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG005 | Lorazepam, Placebo | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
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| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
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| Pregabalin High Dose, Placebo |
Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG002 | Pregabalin Low Dose, Pregabalin Low Dose | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG003 | Pregabalin Low Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG004 | Lorazepam, Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG005 | Lorazepam, Placebo | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
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| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
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| Pregabalin High Dose, Placebo |
Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG002 | Pregabalin Low Dose, Pregabalin Low Dose | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG003 | Pregabalin Low Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG004 | Lorazepam, Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG005 | Lorazepam, Placebo | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
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| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
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| Pregabalin High Dose, Placebo |
Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG002 | Pregabalin Low Dose, Pregabalin Low Dose | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG003 | Pregabalin Low Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG004 | Lorazepam, Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG005 | Lorazepam, Placebo | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
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| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
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| Pregabalin High Dose, Placebo |
Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG002 | Pregabalin Low Dose, Pregabalin Low Dose | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG003 | Pregabalin Low Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG004 | Lorazepam, Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG005 | Lorazepam, Placebo | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
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| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
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| Pregabalin High Dose, Placebo |
Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG002 | Pregabalin Low Dose, Pregabalin Low Dose | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG003 | Pregabalin Low Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG004 | Lorazepam, Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG005 | Lorazepam, Placebo | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
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| OG002 | Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. |
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| OG001 | Pregabalin High Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG002 | Pregabalin Low Dose, Pregabalin Low Dose | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG003 | Pregabalin Low Dose, Placebo | Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG004 | Lorazepam, Lorazepam | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26). |
| OG005 | Lorazepam, Placebo | Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26). |
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