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This is a 6-week, randomised, multicenter, double-blind, placebo controlled, fixed dose parallel group study to assess the efficacy and safety of orvepitant (30 and 60 mg/day) versus placebo in subjects with a diagnosis of a Major Depressive Disorder, whose symptoms are considered moderate or severe.
Following an initial screening visit, subjects fulfilling the study inclusion and exclusion criteria will enter a pre-treatment screening phase to permit evaluation of the laboratory and ECG assessments and to confirm eligibility for inclusion into the study. This screening phase will be a minimum of 7 days, but no longer than 21 days. At the completion of the screening period, eligible subjects will be randomised at the baseline visit to receive either orvepitant 30mg/day, orvepitant 60mg/day or placebo (equal chance of receiving any of the three possible treatments, i.e., a 1:1:1 ratio) for a six-week double-blind treatment phase. Those subjects randomised to receive placebo will receive study medication identical in appearance to that received by subjects assigned to receive orvepitant 30 or 60mg/day.
Efficacy will be assessed via standard depression symptom and severity rating scales or questionaires. The Hamilton Depression Rating Scale (HAM-D) will be used as the primary measure. Secondary efficacy endpoints include the Quick Inventory of Depressive Symptomatology (QIDS-SR) and the Clinical Global Impression- Global Improvement and Severity of Illness Scale (CGI-I and CGI-S, respectively).
Safety will be assessed by monitoring for adverse events (side effects) and through periodic laboratory evaluations (blood tests), vital signs assessments (e.g., blood pressure, heart rate, temperature) and heart function measurements (electrocardiograms, or ECGs).
The purpose of the current study is to test the safety and the anti-depressant effects of orvepitant, an investigational antidepressant. Efficacy will be assessed using standard depression symptom and severity rating scales (questionaires). The Hamilton Depression Rating Scale (HAM-D) will serve as the primary measure of efficacy, and . Secondary efficacy endpoints include the Bech Melancholia Scale (sum of items 1, 2, 7, 8, 10, and 13 of the 17-item HAM-D scale), the Quick Inventory of Depressive Symptomatology (QIDS-SR), the Clinical Global Impression- Global Improvement and Severity of Illness Scale (CGI-I and CGI-S, respectively), the HAM-D anxiety factor score (sum of items 10, 11, 12, 13, 15 and 17), the Cognitive and Physical Function Questionnaire (CPFQ) and a morning sleep questionnaire.
Safety and tolerability will be assessed by monitoring adverse events (AEs or side effects), physical examinations (including vital signs such as blood pressure and heart rate), clinical laboratory assessments (blood tests), electrical recordings of the heart (electrocardiograms or ECG's), the Columbia Suicidality Severity Rating Scale (CSSRS), Sexual Function Questionnaire (SFQ), and weight change.
Blood samples will be taken at different time points to assess blood levels of orvepitant in patients, allowing the relationship between amount of orvepitant in the body and efficacy to be studied.
The primary objective of the study is to evaluate the antidepressant efficacy of orvepitant (30 and 60mg/day) versus placebo (a "sugar pill", with no active ingredients). The secondary objectives include assessing the safety and tolerability of orvepitant, assessing the profile of appearance and disappearance of orvepitant in the body (blood) following administration (i.e., assessing how long the drug remains in the body), and lastly to examine the relationship between blood levels of the drug and efficacy (i..e, the change in HAM-D total score relative to what it was before starting the study medication.
Following an initial screening visit, subjects fulfilling the study entrance criteria will enter a pre-treatment screening phase to permit evaluation of the laboratory and electrocardiogram assessments and to confirm eligibility for inclusion into the study. This screening phase will be a minimum of 7 days, but no longer than 21 days. During the screening period, subjects may undergo up to three different assessments of their depressive symptoms, this may occur via a face-to-face interview or via an interview over the telephone. Upon completion of the screening period, eligible subjects will be randomly assigned at the baseline visit to one of three treatment regimens: orvepitant 30mg/day, orvepitant 60mg/day or placebo for a six-week treatment phase. The chances of receiving each of the three possible treatments will be equal. Orvepitant will be administered as tablets. Those subjects randomised to receive placebo will receive study medication identical in appearance to that received by subjects assigned to receive orvepitant.
During the treatment phase, subjects will be required to return to the clinic at the end of Weeks 1, 2, 4 and 6. In addition, all subjects will be required to return for a follow-up visit 14 days after the last dose of study medication. In addition, all subjects with ongoing adverse events at the 14-day follow-up visit will be required to return for a further follow-up visit 28 days after the last dose of study medication.
Male and female outpatients between the ages of 18 to 64 years inclusive with a primary diagnosis of Major Depressive Disorder will be enrolled into this study. A total of approximately 350 subjects are expected to be enrolled at approximately 20 different study sites in the U.S. and Canada.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | inactive placebo to match orvepitant 30 and 60 mg dosage forms |
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| Orvepitant 30 mg | Experimental | 30 mg/day (low dose) |
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| Orvepitant 60 mg | Experimental | 60 mg/day (high dose) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| orvepitant | Drug | Neurokinin-1 (NK-1) antagonist |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) Total Score | The HAM-D is designed to measure severity of depressive symptoms in participants with primary depressive illness. The scale is a checklist of items (1: depressed mood, 2: feelings of guilt, 3: suicide, insomnia early, 4: insomnia early, 5: insomnia middle, 6: insomnia late, 7: work and activities, 8: retardation, 9: agitation, 10: anxiety psychic item 10: anxiety psychic, item 11: anxiety somatic, item 12: somatic symptoms gastrointestinal, 13: somatic symptoms general, 14: genital symptoms, 15: hypochondriasis, 16: loss of weight and 17: insight) that are ranked on a scale of 0 to 4 or 0 to 2 (4 and 2: highly severe and 0: not present). The HAM-D total score is calculated by summing individual response scores on the HAM-D questionnaire. The highest possible score is 52, representing most severe measure of depression; lowest possible score is 0, representing no depression. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. | Baseline (Day 1) to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a >= 50 Percent (%) Reduction From Baseline in HAM-D Total Score | Participants who had 50% or greater reduction from Baseline in their total HAMD score were termed as responders. The HAM-D was designed to measure the severity of depressive symptoms in participants with primary depressive illness. The scale is a checklist of items that are ranked on a scale of 0 to 4 or 0 to 2. Items with quantifiable severity are scored 0 to 4 (4 indicating the greatest severity) or 0 to 2 (2 indicating the greatest severity) with 0 indicating not present. The HAM-D Total Score is calculated by summing the individual response scores on the HAM-D questionnaire. The highest possible score is 52, which represents the most severe measure of depression; the lowest possible score is 0, which represents an absence of depression. The HAM-D is also useful for monitoring changes in depressive symptoms with treatment and in comparing the efficacy of various interventions if the participant requires more than one type of treatment. Baseline was Day 1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35216 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23539641 | Background | Ratti E, Bettica P, Alexander R, Archer G, Carpenter D, Evoniuk G, Gomeni R, Lawson E, Lopez M, Millns H, Rabiner EA, Trist D, Trower M, Zamuner S, Krishnan R, Fava M. Full central neurokinin-1 receptor blockade is required for efficacy in depression: evidence from orvepitant clinical studies. J Psychopharmacol. 2013 May;27(5):424-34. doi: 10.1177/0269881113480990. Epub 2013 Mar 28. |
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A total of 787 participants were screened for study eligibility, of which 331 participants were randomized. Out of 331 participants, 3 did not receive the study medication. All subjects population included all participants who had received at least one dose of the study medication and comprised of 328 participants.
This study was conducted at 20 centers across the United States of America (USA) (17 centers) and Canada (3 centers) from 04 March 2009 to 16 June 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks. |
| FG001 | Orvepitant 30 mg | Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| placebo | Other | inactive placebo to match orvepitant 30 and 60 mg dosage forms |
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| Baseline (Day 1) to Week 6 |
| Number of Participants With (Maintained) Clinical Response | Clinical response or antidepressant response was defined as >= 50% reduction from randomization in their HAMD total score, where this response was maintained until the end of the Treatment Phase (Week 6). Participants who met the >= 50% reduction at Week 6 without also having met it at Week 4 were not considered to have reached a maintained response, and therefore were censored at Week 6. Number of participants with maintained clinical response are reported. | Up to Week 6 |
| Change From Baseline in the Bech Melancholia Scale Total Score (Sum of Items 1, 2, 7, 8, 10, and 13 of the 17-item HAMD Scale) | The Bech Melancholia is sum of scores on 6 items/questions (item 1: depressed mood, item 2: feelings of guilt, item 7: work and activities, item 8: retardation, item 10: anxiety psychic and item 13: somatic symptoms general) pertaining to melancholia within HAM-D. The items are rated on a scale of 0 to 4 (items 1, 2, 7, 8 and 10) or 0 to 2 (item 13), higher scores reflecting greater severity. The highest possible score is 24, which represents the most severe measure of melancholy; the lowest possible score is 0, which represents an absence of melancholy. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. | Baseline (Day 1) to Week 6 |
| Change From Baseline in the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR 16) Total Score | The QIDS-SR is a self-report rating scale that assesses symptom severity of major depressive disorders. The QIDS-SR utilized during this study contained 16 separate items which correspond to 9 symptom criterion domains: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation,(5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation. The QIDS-SR total score was calculated using the sum of the domain scores. The highest possible total QIDS-SR score is 27, which represents the most severe measure of depression. The lowest possible score is 0, which represents an absence of depression. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. | Baseline (Day 1) to Week 6 |
| Change From Baseline in the HAM-D Anxiety Factor Score (Sum of Items 10, 11, 12, 13, 15 and 17) | The HAMD anxiety factor score includes 6 items/questions (item 10: anxiety psychic, item 11: anxiety somatic, item 12: somatic symptoms gastrointestinal, item 13: somatic symptoms general, item 15: hypochondriasis and item 17: insight). The items are rated on a scale of 0 to 4 (items 10, 11 and 15) or 0 to 2 (items 12, 13 and 17), higher scores reflecting greater severity. The highest possible score is 18, which represents the most severe measure of anxiety; the lowest possible score is 0, which represents an absence of anxiety. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. | Baseline (Day 1) to Week 6 |
| Percentage of Participants With Clinical Global Impression- Global Improvement (CGI-I) Score of 1 (Very Much Improved) or 2 (Much Improved) | The CGI is a widely accepted measure of illness severity and clinical improvement in a variety of psychiatric disorders. Global improvement (CGI-I) item is rated on a 1-7 scale. The CGI-I assessed scores range from 1 - very much improved to 7 - very much worse. For the CGI-I, the investigator or delegated qualified clinician indicated their assessment of the participant's total improvement or worsening compared with the individual's condition at the start of the study whether or not the change was judged to be due to drug treatment. A participant with a CGI-I score of 1 'very much improved' or 2 'much improved' was considered a responder. Percentage of responders are reported. | Up to Week 6 |
| Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score | The CGI is a widely accepted measure of illness severity and clinical improvement in a variety of psychiatric disorders. For the CGI-S, an independent site rater assessed the participant's severity of illness considering (1) their total clinical experience with the particular population being studied and (2) information obtained during the Baseline HAM-D interview with the participant. The severity of illness (CGI-S) item is rated on a 1 to 7 scale such that 1 (normal, not at all ill) and 7 (among the most extremely ill). Higher scores indicate worsening. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. | Baseline (Day 1) to Week 6 |
| Change From Baseline in the Cognitive and Physical Function Questionnaire (CPFQ) Total Score | The CPFQ is a brief self-report scale which is designed to measure cognitive and executive dysfunction in mood and anxiety disorders. The scale comprises 7 questions assessing each of the most common complaints of depressed participants reporting fatigue or cognitive/executive problems. Each question is rated on a scale of 1 to 6, (1 = greater than normal; 2 = normal; 3 = minimally diminished; 4=moderately diminished; 5 = markedly diminished; and 6 = totally absent). The following five areas were included: motivation/interest/enthusiasm; wakefulness/alertness; energy; focus/sustain attention; remember/recall information; find words and sharpness/mental acuity. The total score (sum of individual question scores) ranged from 7 to 42. Lower score 7 represents greater than normal functioning and higher score 42 indicate poorer functioning (worst outcome). Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. | Baseline (Day 1) and Week 6 |
| Change From Baseline in Morning Sleep Questionnaire (MSQ) Values for Total Sleep Time (TST), Sleep Onset Latency (SOL) and Wake Time After Sleep Onset (WTSO) | The MSQ is a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following six variables were assessed in order to determine effects on sleep: (1) total sleep time, (2) sleep onset latency, (3) number of nocturnal awakenings, (4) wake time after sleep onset, (5) sleep quality (where poor=1 and excellent= 10) and (6) the refreshing value of the sleep (where poor=1 and excellent= 10). During the conduct of the study, participants self-administered the MSQ via an Interactive Voice Response System (IVRS) from their home the morning of each clinic visit. Participants were provided paper MSQ diary cards for note taking prior to completing the IVRS call. If a participant did not remember to place the IVRS MSQ call the morning of the clinic visit from home, they were allowed to place the call during in the clinic during their visit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. | Baseline (Day 1) to Week 6 |
| Change From Baseline in MSQ Values for Number of Nocturnal Awakenings | The MSQ is a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following six variables were assessed in order to determine effects on sleep: (1) total sleep time, (2) sleep onset latency, (3) number of nocturnal awakenings, (4) wake time after sleep onset, (5) sleep quality (where poor=1 and excellent= 10) and (6) the refreshing value of the sleep (where poor=1 and excellent= 10). During the conduct of the study, participants self-administered the MSQ via an Interactive Voice Response System (IVRS) from their home the morning of each clinic visit. Participants were provided paper MSQ diary cards for note taking prior to completing the IVRS call. If a participant did not remember to place the IVRS MSQ call the morning of the clinic visit from home, they were allowed to place the call during in the clinic during their visit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. | Baseline (Day 1) to Week 6 |
| Change From Baseline in MSQ Values for Sleep Quality (SQ) and Refreshing Value of Sleep (RVS) | The MSQ is a self-rated scale designed to assess effects on sleep and effects on next day functioning. The score relating to SQ and RVS was measured by items/questions 4 and 5 respectively of the MSQ. The following two variables SQ and RVS were assessed in order to determine effects on sleep. Participants were asked to rate their SQ and RVS on a scale of 1 to 10. This scale has no subscales. The total score for SQ and RVS, both, ranged from 1 to 10 where 1=poor and 10=excellent. Lower scores indicated poor SQ and RVS and higher scores indicated excellent SQ and excellent RVS. During the conduct of study, participants self-administered MSQ via an IVRS from their home the morning of each clinic visit. If a participant did not remember to place IVRS MSQ call the morning of the clinic visit from home, they were allowed to place call during in the clinic during their visit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. | Baseline (Day 1) to Week 6 |
| Number of Participants Who Remit (Have an Endpoint HAM-D Total Score <= 7) Who Continue to Show Symptoms on the HAM-D Sleep Items | A HAM-D remitter was defined as a participant with a HAM-D total score less than or equal to 7. The HAM-D was designed to measure the severity of depressive symptoms in participants with primary depressive illness. The scale is a checklist of items that are ranked on a scale of 0 to 4 or 0 to 2. Items with quantifiable severity are scored 0 to 4 (4 indicating the greatest severity) or 0 to 2 (2 indicating the greatest severity) with 0 indicating not present. The HAM-D Total Score is calculated by summing the individual response scores on the HAM-D questionnaire. The highest possible score is 52, which represents the most severe measure of depression; the lowest possible score is 0, which represents an absence of depression. The HAM-D is also useful for monitoring changes in depressive symptoms with treatment and in comparing the efficacy of various interventions if the participant requires more than one type of treatment. | Up to Week 6 |
| Number of Participants With Suicidal Behavior, Ideation, and Most Common Ideation Using the Columbia Suicidality Severity Rating Scale (C-SSRS) | The C-SSRS is a clinician-rated scale that evaluates severity and change of suicidality by integrating both behavior and ideation. It has 3 sections, Suicidal Behavior (SB), Suicidal Ideation (SI) and Intensity of Ideation (II). For SB, participants (par) were scored non-suicidal:0, preparatory acts or behavior communicating ideation:1, aborted attempt:2, interrupted attempt:3 or actual attempt:4 (most severe). For SI, par were scored non-suicidal:0, wish to be dead:1, non-specific active suicidal thoughts:2, active suicidal ideation with associated thoughts of methods without intent:3, active suicidal ideation with some intent to act on suicidal thoughts without clear plan:4, active suicidal ideation with plan and intent:5 (most severe). II scale made of 5 questions measuring frequency, duration, controllability, deterrent and reasons; par received a separate score on most common ideation and on most severe. Total II score is obtained by adding scores from all 5 questions. | Week 8 |
| Number of Discontinuation-emergent Signs and Symptoms Using the Discontinuation-Emergent Signs and Symptoms (DESS) | The discontinuation signs and symptoms scale consists of 43 signs and symptoms, scored as 'new symptom', 'old symptom but worse', 'old symptom but improved' or ' symptom not present/old symptom but unchanged'. A frequency table for each symptom is reported by treatment and visit. The total number of new signs and symptoms, old symptoms but worse, old symptoms but improved and the total number of new or old-but-worse signs and symptoms are calculated for treatment and visit and reported. | Week 1 to Week 8/Follow up 1 |
| Change From Baseline in the Massachusetts Sexual Function Questionnaire (MSFQ)-Males | The MSFQ is a self report rating scale derived from the Guided Interview Questionnaire for females and males. The questionnaire includes five questions with a score for each question ranging from 1 to 6 (1 = greater than normal; 2 = normal; 3 = minimally diminished; 4=moderately diminished; 5 = markedly diminished; and 6 = totally absent). The following five areas of sexual functioning were included: (1) diminished/absent libido; (2) arousal difficulties; (3) orgasm difficulties/anorgasmia; (4) erectile dysfunction (males only) and (5) degree of sexual satisfaction. A total score (sum of individual question score) was used as a global measure of sexual dysfunction which ranged from 5 to 30, where 5 represents greater than normal functioning and 30 represents poorer function (worst outcome). Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. A negative change from Baseline was considered a positive outcome. | Baseline (Day 1) to Week 6 |
| Change From Baseline in the MSFQ Total Score-Females | The MSFQ is a self report rating scale derived from the Guided Interview Questionnaire for females and males. The questionnaire includes five questions with a score for each question ranging from 1 to 6 (1 = greater than normal; 2 = normal; 3 = minimally diminished; 4=moderately diminished; 5 = markedly diminished; and 6 = totally absent). The following four areas of sexual functioning were included: (1) diminished/absent libido; (2) arousal difficulties; (3) orgasm difficulties/anorgasmia; and (4) degree of sexual satisfaction. A total score (sum of individual question score) was used as a global measure of sexual dysfunction which ranged from 4 to 24, where 5 represents greater than normal functioning and 24 represents poorer function (worst outcome). Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. A negative change from Baseline was considered a positive outcome. | Baseline (Day 1) to Week 6 |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| GSK Investigational Site | Arcadia | California | 91007 | United States |
| GSK Investigational Site | Beverly Hills | California | 90210 | United States |
| GSK Investigational Site | National City | California | 91950 | United States |
| GSK Investigational Site | Upland | California | 91786 | United States |
| GSK Investigational Site | Bradenton | Florida | 34208 | United States |
| GSK Investigational Site | Maitland | Florida | 32751 | United States |
| GSK Investigational Site | North Miami | Florida | 33161 | United States |
| GSK Investigational Site | Orlando | Florida | 32806 | United States |
| GSK Investigational Site | Overland Park | Kansas | 66212 | United States |
| GSK Investigational Site | New York | New York | 10029 | United States |
| GSK Investigational Site | The Bronx | New York | 10467 | United States |
| GSK Investigational Site | Toledo | Ohio | 43623 | United States |
| GSK Investigational Site | Lincoln | Rhode Island | 02868 | United States |
| GSK Investigational Site | Seattle | Washington | 98104 | United States |
| GSK Investigational Site | Middleton | Wisconsin | 53562 | United States |
| GSK Investigational Site | Burlington | Ontario | L7R 4E2 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K1C 1T1 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5G 2C4 | Canada |
| FG002 | Orvepitant 60 mg | Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks. |
| BG001 | Orvepitant 30 mg | Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. |
| BG002 | Orvepitant 60 mg | Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) Total Score | The HAM-D is designed to measure severity of depressive symptoms in participants with primary depressive illness. The scale is a checklist of items (1: depressed mood, 2: feelings of guilt, 3: suicide, insomnia early, 4: insomnia early, 5: insomnia middle, 6: insomnia late, 7: work and activities, 8: retardation, 9: agitation, 10: anxiety psychic item 10: anxiety psychic, item 11: anxiety somatic, item 12: somatic symptoms gastrointestinal, 13: somatic symptoms general, 14: genital symptoms, 15: hypochondriasis, 16: loss of weight and 17: insight) that are ranked on a scale of 0 to 4 or 0 to 2 (4 and 2: highly severe and 0: not present). The HAM-D total score is calculated by summing individual response scores on the HAM-D questionnaire. The highest possible score is 52, representing most severe measure of depression; lowest possible score is 0, representing no depression. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. | The Intent-to-Treat (ITT) population comprised of all participants who were randomized and received at least one dose of double blind medication and for whom at least one post-randomization assessment was available. Only those participants available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Scores on a Scale | Baseline (Day 1) to Week 6 |
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| Secondary | Percentage of Participants With a >= 50 Percent (%) Reduction From Baseline in HAM-D Total Score | Participants who had 50% or greater reduction from Baseline in their total HAMD score were termed as responders. The HAM-D was designed to measure the severity of depressive symptoms in participants with primary depressive illness. The scale is a checklist of items that are ranked on a scale of 0 to 4 or 0 to 2. Items with quantifiable severity are scored 0 to 4 (4 indicating the greatest severity) or 0 to 2 (2 indicating the greatest severity) with 0 indicating not present. The HAM-D Total Score is calculated by summing the individual response scores on the HAM-D questionnaire. The highest possible score is 52, which represents the most severe measure of depression; the lowest possible score is 0, which represents an absence of depression. The HAM-D is also useful for monitoring changes in depressive symptoms with treatment and in comparing the efficacy of various interventions if the participant requires more than one type of treatment. Baseline was Day 1. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Number | Percentage of participants | Baseline (Day 1) to Week 6 |
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| Secondary | Number of Participants With (Maintained) Clinical Response | Clinical response or antidepressant response was defined as >= 50% reduction from randomization in their HAMD total score, where this response was maintained until the end of the Treatment Phase (Week 6). Participants who met the >= 50% reduction at Week 6 without also having met it at Week 4 were not considered to have reached a maintained response, and therefore were censored at Week 6. Number of participants with maintained clinical response are reported. | ITT Population. | Posted | Number | Participants | Up to Week 6 |
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| Secondary | Change From Baseline in the Bech Melancholia Scale Total Score (Sum of Items 1, 2, 7, 8, 10, and 13 of the 17-item HAMD Scale) | The Bech Melancholia is sum of scores on 6 items/questions (item 1: depressed mood, item 2: feelings of guilt, item 7: work and activities, item 8: retardation, item 10: anxiety psychic and item 13: somatic symptoms general) pertaining to melancholia within HAM-D. The items are rated on a scale of 0 to 4 (items 1, 2, 7, 8 and 10) or 0 to 2 (item 13), higher scores reflecting greater severity. The highest possible score is 24, which represents the most severe measure of melancholy; the lowest possible score is 0, which represents an absence of melancholy. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Scores on a Scale | Baseline (Day 1) to Week 6 |
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| Secondary | Change From Baseline in the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR 16) Total Score | The QIDS-SR is a self-report rating scale that assesses symptom severity of major depressive disorders. The QIDS-SR utilized during this study contained 16 separate items which correspond to 9 symptom criterion domains: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation,(5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation. The QIDS-SR total score was calculated using the sum of the domain scores. The highest possible total QIDS-SR score is 27, which represents the most severe measure of depression. The lowest possible score is 0, which represents an absence of depression. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Scores on a Scale | Baseline (Day 1) to Week 6 |
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| Secondary | Change From Baseline in the HAM-D Anxiety Factor Score (Sum of Items 10, 11, 12, 13, 15 and 17) | The HAMD anxiety factor score includes 6 items/questions (item 10: anxiety psychic, item 11: anxiety somatic, item 12: somatic symptoms gastrointestinal, item 13: somatic symptoms general, item 15: hypochondriasis and item 17: insight). The items are rated on a scale of 0 to 4 (items 10, 11 and 15) or 0 to 2 (items 12, 13 and 17), higher scores reflecting greater severity. The highest possible score is 18, which represents the most severe measure of anxiety; the lowest possible score is 0, which represents an absence of anxiety. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Scores on a Scale | Baseline (Day 1) to Week 6 |
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| Secondary | Percentage of Participants With Clinical Global Impression- Global Improvement (CGI-I) Score of 1 (Very Much Improved) or 2 (Much Improved) | The CGI is a widely accepted measure of illness severity and clinical improvement in a variety of psychiatric disorders. Global improvement (CGI-I) item is rated on a 1-7 scale. The CGI-I assessed scores range from 1 - very much improved to 7 - very much worse. For the CGI-I, the investigator or delegated qualified clinician indicated their assessment of the participant's total improvement or worsening compared with the individual's condition at the start of the study whether or not the change was judged to be due to drug treatment. A participant with a CGI-I score of 1 'very much improved' or 2 'much improved' was considered a responder. Percentage of responders are reported. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Number | Percentage of participants | Up to Week 6 |
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| Secondary | Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score | The CGI is a widely accepted measure of illness severity and clinical improvement in a variety of psychiatric disorders. For the CGI-S, an independent site rater assessed the participant's severity of illness considering (1) their total clinical experience with the particular population being studied and (2) information obtained during the Baseline HAM-D interview with the participant. The severity of illness (CGI-S) item is rated on a 1 to 7 scale such that 1 (normal, not at all ill) and 7 (among the most extremely ill). Higher scores indicate worsening. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Scores on a Scale | Baseline (Day 1) to Week 6 |
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| Secondary | Change From Baseline in the Cognitive and Physical Function Questionnaire (CPFQ) Total Score | The CPFQ is a brief self-report scale which is designed to measure cognitive and executive dysfunction in mood and anxiety disorders. The scale comprises 7 questions assessing each of the most common complaints of depressed participants reporting fatigue or cognitive/executive problems. Each question is rated on a scale of 1 to 6, (1 = greater than normal; 2 = normal; 3 = minimally diminished; 4=moderately diminished; 5 = markedly diminished; and 6 = totally absent). The following five areas were included: motivation/interest/enthusiasm; wakefulness/alertness; energy; focus/sustain attention; remember/recall information; find words and sharpness/mental acuity. The total score (sum of individual question scores) ranged from 7 to 42. Lower score 7 represents greater than normal functioning and higher score 42 indicate poorer functioning (worst outcome). Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Scores on a Scale | Baseline (Day 1) and Week 6 |
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| Secondary | Change From Baseline in Morning Sleep Questionnaire (MSQ) Values for Total Sleep Time (TST), Sleep Onset Latency (SOL) and Wake Time After Sleep Onset (WTSO) | The MSQ is a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following six variables were assessed in order to determine effects on sleep: (1) total sleep time, (2) sleep onset latency, (3) number of nocturnal awakenings, (4) wake time after sleep onset, (5) sleep quality (where poor=1 and excellent= 10) and (6) the refreshing value of the sleep (where poor=1 and excellent= 10). During the conduct of the study, participants self-administered the MSQ via an Interactive Voice Response System (IVRS) from their home the morning of each clinic visit. Participants were provided paper MSQ diary cards for note taking prior to completing the IVRS call. If a participant did not remember to place the IVRS MSQ call the morning of the clinic visit from home, they were allowed to place the call during in the clinic during their visit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Minutes (mins) | Baseline (Day 1) to Week 6 |
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| Secondary | Change From Baseline in MSQ Values for Number of Nocturnal Awakenings | The MSQ is a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following six variables were assessed in order to determine effects on sleep: (1) total sleep time, (2) sleep onset latency, (3) number of nocturnal awakenings, (4) wake time after sleep onset, (5) sleep quality (where poor=1 and excellent= 10) and (6) the refreshing value of the sleep (where poor=1 and excellent= 10). During the conduct of the study, participants self-administered the MSQ via an Interactive Voice Response System (IVRS) from their home the morning of each clinic visit. Participants were provided paper MSQ diary cards for note taking prior to completing the IVRS call. If a participant did not remember to place the IVRS MSQ call the morning of the clinic visit from home, they were allowed to place the call during in the clinic during their visit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Awakenings | Baseline (Day 1) to Week 6 |
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| Secondary | Change From Baseline in MSQ Values for Sleep Quality (SQ) and Refreshing Value of Sleep (RVS) | The MSQ is a self-rated scale designed to assess effects on sleep and effects on next day functioning. The score relating to SQ and RVS was measured by items/questions 4 and 5 respectively of the MSQ. The following two variables SQ and RVS were assessed in order to determine effects on sleep. Participants were asked to rate their SQ and RVS on a scale of 1 to 10. This scale has no subscales. The total score for SQ and RVS, both, ranged from 1 to 10 where 1=poor and 10=excellent. Lower scores indicated poor SQ and RVS and higher scores indicated excellent SQ and excellent RVS. During the conduct of study, participants self-administered MSQ via an IVRS from their home the morning of each clinic visit. If a participant did not remember to place IVRS MSQ call the morning of the clinic visit from home, they were allowed to place call during in the clinic during their visit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Scores on a Scale | Baseline (Day 1) to Week 6 |
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| Secondary | Number of Participants Who Remit (Have an Endpoint HAM-D Total Score <= 7) Who Continue to Show Symptoms on the HAM-D Sleep Items | A HAM-D remitter was defined as a participant with a HAM-D total score less than or equal to 7. The HAM-D was designed to measure the severity of depressive symptoms in participants with primary depressive illness. The scale is a checklist of items that are ranked on a scale of 0 to 4 or 0 to 2. Items with quantifiable severity are scored 0 to 4 (4 indicating the greatest severity) or 0 to 2 (2 indicating the greatest severity) with 0 indicating not present. The HAM-D Total Score is calculated by summing the individual response scores on the HAM-D questionnaire. The highest possible score is 52, which represents the most severe measure of depression; the lowest possible score is 0, which represents an absence of depression. The HAM-D is also useful for monitoring changes in depressive symptoms with treatment and in comparing the efficacy of various interventions if the participant requires more than one type of treatment. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Number | Participants | Up to Week 6 |
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| Secondary | Number of Participants With Suicidal Behavior, Ideation, and Most Common Ideation Using the Columbia Suicidality Severity Rating Scale (C-SSRS) | The C-SSRS is a clinician-rated scale that evaluates severity and change of suicidality by integrating both behavior and ideation. It has 3 sections, Suicidal Behavior (SB), Suicidal Ideation (SI) and Intensity of Ideation (II). For SB, participants (par) were scored non-suicidal:0, preparatory acts or behavior communicating ideation:1, aborted attempt:2, interrupted attempt:3 or actual attempt:4 (most severe). For SI, par were scored non-suicidal:0, wish to be dead:1, non-specific active suicidal thoughts:2, active suicidal ideation with associated thoughts of methods without intent:3, active suicidal ideation with some intent to act on suicidal thoughts without clear plan:4, active suicidal ideation with plan and intent:5 (most severe). II scale made of 5 questions measuring frequency, duration, controllability, deterrent and reasons; par received a separate score on most common ideation and on most severe. Total II score is obtained by adding scores from all 5 questions. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Number | Participants | Week 8 |
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| Secondary | Number of Discontinuation-emergent Signs and Symptoms Using the Discontinuation-Emergent Signs and Symptoms (DESS) | The discontinuation signs and symptoms scale consists of 43 signs and symptoms, scored as 'new symptom', 'old symptom but worse', 'old symptom but improved' or ' symptom not present/old symptom but unchanged'. A frequency table for each symptom is reported by treatment and visit. The total number of new signs and symptoms, old symptoms but worse, old symptoms but improved and the total number of new or old-but-worse signs and symptoms are calculated for treatment and visit and reported. | All subjects population comprised of all participants who received at least one dose of study medication. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Signs and symptoms | Week 1 to Week 8/Follow up 1 |
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| Secondary | Change From Baseline in the Massachusetts Sexual Function Questionnaire (MSFQ)-Males | The MSFQ is a self report rating scale derived from the Guided Interview Questionnaire for females and males. The questionnaire includes five questions with a score for each question ranging from 1 to 6 (1 = greater than normal; 2 = normal; 3 = minimally diminished; 4=moderately diminished; 5 = markedly diminished; and 6 = totally absent). The following five areas of sexual functioning were included: (1) diminished/absent libido; (2) arousal difficulties; (3) orgasm difficulties/anorgasmia; (4) erectile dysfunction (males only) and (5) degree of sexual satisfaction. A total score (sum of individual question score) was used as a global measure of sexual dysfunction which ranged from 5 to 30, where 5 represents greater than normal functioning and 30 represents poorer function (worst outcome). Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. A negative change from Baseline was considered a positive outcome. | Only males from all subjects population. Only those participants available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Scores on a Scale | Baseline (Day 1) to Week 6 |
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| Secondary | Change From Baseline in the MSFQ Total Score-Females | The MSFQ is a self report rating scale derived from the Guided Interview Questionnaire for females and males. The questionnaire includes five questions with a score for each question ranging from 1 to 6 (1 = greater than normal; 2 = normal; 3 = minimally diminished; 4=moderately diminished; 5 = markedly diminished; and 6 = totally absent). The following four areas of sexual functioning were included: (1) diminished/absent libido; (2) arousal difficulties; (3) orgasm difficulties/anorgasmia; and (4) degree of sexual satisfaction. A total score (sum of individual question score) was used as a global measure of sexual dysfunction which ranged from 4 to 24, where 5 represents greater than normal functioning and 24 represents poorer function (worst outcome). Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. A negative change from Baseline was considered a positive outcome. | Only females from all subjects population. Only those participants available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Scores on a Scale | Baseline (Day 1) to Week 6 |
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Serious adverse events (SAE) and non-serious adverse events (nSAE) were collected from Screening (Visit1), at Baseline (Day 1, Visit 2) until follow-up (Day 28, Visit 5).
SAEs and nSAE are reported for all subjects population which comprised of all participants who received at least one dose of study medication.
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 | Placebo | Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks. | 0 | 108 | 1 | 108 | 27 | 108 |
| EG001 | Orvepitant 30 mg | Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. | 0 | 113 | 0 | 113 | 40 | 113 |
| EG002 | Orvepitant 60 mg | Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. | 0 | 107 | 1 | 107 | 34 | 107 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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The study was terminated early upon recommendation of IDMC that was reviewing data from this trial and two other ongoing trials with same drug. When the trial was terminated 331 participants were randomized, compared to a target of 348 participants.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| C584555 | orvepitant |
Not provided
Not provided
Not provided
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Week 2 |
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| Week 4 |
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| Week 6 |
|
|
| Mixed Models Repeated Measures |
| 0.0586 |
| Mean Difference (Net) |
| -1.15 |
| 2-Sided |
| 95 |
| -2.34 |
| 0.04 |
| Superiority or Other |
| Placebo Vs Orvepitatnt 30 mg at Week 2 | Mixed Models Repeated Measures | 0.0111 | Mean Difference (Net) | -1.89 | 2-Sided | 95 | -3.34 | -0.43 | Superiority or Other |
| Placebo Vs Orvepitatnt 60 mg at Week 2 | Mixed Models Repeated Measures | 0.0141 | Mean Difference (Net) | -1.84 | 2-Sided | 95 | -3.30 | -0.37 | Superiority or Other |
| Placebo Vs Orvepitatnt 30 mg at Week 4 | Mixed Models Repeated Measures | 0.0152 | Mean Difference (Net) | -2.22 | 2-Sided | 95 | -4.00 | -0.43 | Superiority or Other |
| Placebo Vs Orvepitatnt 60 mg at Week 4 | Mixed Models Repeated Measures | 0.0010 | Mean Difference (Net) | -3.06 | 2-Sided | 95 | -4.86 | -1.25 | Superiority or Other |
| Placebo Vs Orvepitatnt 30 mg at Week 6 | Mixed Models Repeated Measures | 0.0245 | Mean Difference (Net) | -2.41 | 2-Sided | 95 | -4.50 | -0.31 | Superiority or Other |
| Placebo Vs Orvepitatnt 60 mg at Week 6 | Mixed Models Repeated Measures | 0.0082 | Mean Difference (Net) | -2.86 | 2-Sided | 95 | -4.97 | -0.75 | Superiority or Other |
| OG002 | Orvepitant 60 mg | Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. |
|
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| Units | Counts |
|---|---|
| Participants |
|
|
|
Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. |
|
|
|
| OG002 | Orvepitant 60 mg | Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. |
|
|
|
Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. |
|
|
|
Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. |
|
|
|
Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. |
|
|
|
| OG002 | Orvepitant 60 mg | Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. |
|
|
|
Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. |
| OG002 | Orvepitant 60 mg | Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. |
|
|
|
| OG002 | Orvepitant 60 mg | Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. |
|
|
|
Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
| OG002 | Orvepitant 60 mg | Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. |
|
|
|
| OG002 | Orvepitant 60 mg | Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. |
|
|
Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
| OG002 | Orvepitant 60 mg | Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. |
|
|
Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
|
|
Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
| OG002 | Orvepitant 60 mg | Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. |
|
|
|
| OG002 | Orvepitant 60 mg | Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. |
|
|
|