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The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed dose levels of vilazodone compared to placebo in patients with major depressive disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. |
|
| Vilazodone 20 mg/day | Experimental | Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11. |
|
| Vilazodone 40 mg/day | Experimental | Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days. |
|
| Citalopram 40 mg/day | Active Comparator | Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vilazodone | Drug | Vilazodone was supplied as film-coated tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10 | The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A negative change score indicates improvement. | Baseline to Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score | The Clinical Global Impressions-Severity scale is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with a patient population with major depressive disorder. In particular, the clinician is asked to respond to the following question: "Considering your total clinical experience with this population, how mentally ill is the patient at this time?" The patient is rated on the following 7-point scale: 1-normal, not at all ill, 2-borderline ill, 3-mildly ill, 4-moderately ill, 5-markedly ill, 6-severely ill, 7-among the most extremely ill patients. A higher score indicates more mental illness. A negative change score indicates improvement. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
Patients with a history of meeting DSM-IV-TR criteria for:
Patients who are considered a suicide risk.
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| Name | Affiliation | Role |
|---|---|---|
| Carl Gommoll, MS | Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 036 | Birmingham | Alabama | 35216 | United States | ||
| Forest Investigative Site 016 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29608461 | Derived | Kornstein S, Chang CT, Gommoll CP, Edwards J. Vilazodone efficacy in subgroups of patients with major depressive disorder: a post-hoc analysis of four randomized, double-blind, placebo-controlled trials. Int Clin Psychopharmacol. 2018 Jul;33(4):217-223. doi: 10.1097/YIC.0000000000000217. | |
| 26693034 | Derived |
Not provided
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. |
| FG001 | Vilazodone 20 mg/Day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
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Not provided
Not provided
|
| Placebo to citalopram | Drug | Placebo to citalopram was supplied as a capsule. |
|
|
| Placebo to vilazodone | Drug | Placebo to vilazodone was supplied as film-coated tablets. |
|
| Citalopram | Drug | Citalopram was supplied as encapsulated tablets. |
|
|
| Baseline to Week 10 |
| Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response | The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A MADRS sustained response was defined as a MADRS total score ≤ 12 for at least the last 2 visits during the double-blind treatment period (Weeks 1-10). A total MADRS score ≤ 12 corresponds to an average score of 1 per item and is indicative of very low level of depressive symptoms. | Baseline to Week 10 |
| Dothan |
| Alabama |
| 36303 |
| United States |
| Forest Investigative Site 033 | Scottsdale | Arizona | 85254 | United States |
| Forest Investigative Site 027 | Fayetteville | Arkansas | 72703 | United States |
| Forest Investigative Site 029 | Cerritos | California | 90703 | United States |
| Forest Investigative Site 002 | Costa Mesa | California | 92626 | United States |
| Forest Investigative Site 019 | Murrieta | California | 92562 | United States |
| Forest Investigative Site 025 | Oceanside | California | 90703 | United States |
| Forest Investigative Site 043 | Orange | California | 92868 | United States |
| Forest Investigative Site 003 | Redlands | California | 92374 | United States |
| Forest Investigative Site 046 | Sherman Oaks | California | 33026 | United States |
| Forest Investigative Site 057 | Upland | California | 91786 | United States |
| Forest Investigative Site 034 | Cromwell | Connecticut | 06416 | United States |
| Forest Investigative Site 038 | Fort Myers | Florida | 33912 | United States |
| Forest Investigative Site 018 | Gainsville | Florida | 32607 | United States |
| Forest Investigative Site 055 | Hallandale | Florida | 33003 | United States |
| Forest Investigative Site 063 | Jacksonville | Florida | 32256 | United States |
| Forest Investigative Site 035 | Miami | Florida | 33134 | United States |
| Forest Investigative Site 030 | Orlando | Florida | 32806 | United States |
| Forest Investigative Site 062 | Orlando | Florida | 32806 | United States |
| Forest Investigative Site 045 | Pembroke Pines | Florida | 33026 | United States |
| Forest Investigative Site 051 | Tampa | Florida | 33613 | United States |
| Forest Investigative Site 032 | West Palm Beach | Florida | 33407 | United States |
| Forest Investigative Site 022 | Winter Park | Florida | 32789 | United States |
| Forest Investigative Site 060 | Atlanta | Georgia | 30328 | United States |
| Forest Investigative Site 037 | Chicago | Illinois | 60634 | United States |
| Forest Investigative Site 050 | Chicago | Illinois | 60640 | United States |
| Forest Investigative Site 040 | Indianapolis | Indiana | 46260 | United States |
| Forest Investigative Site 012 | Lafayette | Indiana | 47905 | United States |
| Forest Investigative Site 053 | Prairie Village | Kansas | 66206 | United States |
| Forest Investigative Site 020 | Baltimore | Maryland | 21208 | United States |
| Forest Investigative Site 031 | Boston | Massachusetts | 02135 | United States |
| Forest Investigative Site 061 | Las Vegas | Nevada | 89102 | United States |
| Forest Investigative Site 024 | Willingboro | New Jersey | 08046 | United States |
| Forest Investigative Site 010 | Albuquerque | New Mexico | 87109 | United States |
| Forest Investigative Site 011 | Albuquerque | New Mexico | 87109 | United States |
| Forest Investigative Site 004 | Brooklyn | New York | 11214 | United States |
| Forest Investigative Site 007 | Cedarhurst | New York | 11516 | United States |
| Forest Investigative Site 058 | New York | New York | 10003 | United States |
| Forest Investigative Site 047 | New York | New York | 10021 | United States |
| Forest Investigative Site 039 | Cincinnati | Ohio | 45227 | United States |
| Forest Investigative Site 042 | Oklahoma City | Oklahoma | 73112 | United States |
| Forest Investigative Site 048 | Oklahoma City | Oklahoma | 73112 | United States |
| Forest Investigative Site 066 | Portland | Oregon | 97210 | United States |
| Forest Investigative Site 014 | Allentown | Pennsylvania | 18104 | United States |
| Forest Investigative Site 049 | Bridgeville | Pennsylvania | 15017 | United States |
| Forest Investigative Site 064 | Memphis | Tennessee | 38119 | United States |
| Forest Investigative Site 013 | Austin | Texas | 78731 | United States |
| Forest Investigative Site 021 | Dallas | Texas | 75230 | United States |
| Forest Investigative Site 059 | Bellevue | Washington | 98007 | United States |
| Forest Investigative Site 065 | Seattle | Washington | 98104 | United States |
| Forest Investigative Site 054 | Spokane | Washington | 99204 | United States |
| Forest Investigative Site 052 | Middleton | Wisconsin | 53562 | United States |
| Forest Investigative Site 056 | Milwaukee | Wisconsin | 53223 | United States |
| Rele S, Millet R, Kim S, Paik JW, Kim S, Masand PS, Patkar AA. An 8-Week Randomized, Double-Blind Trial Comparing Efficacy, Safety, and Tolerability of 3 Vilazodone Dose-Initiation Strategies Following Switch From SSRIs and SNRIs in Major Depressive Disorder. Prim Care Companion CNS Disord. 2015 Aug 6;17(4):10.4088/PCC.14m01734. doi: 10.4088/PCC.14m01734. eCollection 2015. |
| 26039688 | Derived | Clayton AH, Gommoll C, Chen D, Nunez R, Mathews M. Sexual dysfunction during treatment of major depressive disorder with vilazodone, citalopram, or placebo: results from a phase IV clinical trial. Int Clin Psychopharmacol. 2015 Jul;30(4):216-23. doi: 10.1097/YIC.0000000000000075. |
| 25500685 | Derived | Mathews M, Gommoll C, Chen D, Nunez R, Khan A. Efficacy and safety of vilazodone 20 and 40 mg in major depressive disorder: a randomized, double-blind, placebo-controlled trial. Int Clin Psychopharmacol. 2015 Mar;30(2):67-74. doi: 10.1097/YIC.0000000000000057. |
Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
| FG002 | Vilazodone 40 mg/Day | Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days. |
| FG003 | Citalopram 40 mg/Day | Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11. |
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. |
| BG001 | Vilazodone 20 mg/Day | Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11. |
| BG002 | Vilazodone 40 mg/Day | Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days. |
| BG003 | Citalopram 40 mg/Day | Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Weight | Median | Full Range | kg |
| |||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Height | Median | Full Range | cm |
| |||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kilograms per meter squared |
| |||||||||||||||
| Body Mass Index (BMI) | Median | Full Range | kilograms per meter squared |
|
| 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 the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10 | The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A negative change score indicates improvement. | Intent-to-treat population: All randomized participants who received at least 1 dose of placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline to Week 10 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score | The Clinical Global Impressions-Severity scale is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with a patient population with major depressive disorder. In particular, the clinician is asked to respond to the following question: "Considering your total clinical experience with this population, how mentally ill is the patient at this time?" The patient is rated on the following 7-point scale: 1-normal, not at all ill, 2-borderline ill, 3-mildly ill, 4-moderately ill, 5-markedly ill, 6-severely ill, 7-among the most extremely ill patients. A higher score indicates more mental illness. A negative change score indicates improvement. | Intent-to-treat population: All randomized participants who received at least 1 dose of placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline to Week 10 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response | The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A MADRS sustained response was defined as a MADRS total score ≤ 12 for at least the last 2 visits during the double-blind treatment period (Weeks 1-10). A total MADRS score ≤ 12 corresponds to an average score of 1 per item and is indicative of very low level of depressive symptoms. | Intent-to-treat population: All randomized participants who received at least 1 dose of placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to Week 10 |
|
From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
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 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. | 3 | 281 | 124 | 281 | ||
| EG001 | Vilazodone 20 mg/Day | Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11. | 4 | 288 | 168 | 288 | ||
| EG002 | Vilazodone 40 mg/Day | Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days. | 4 | 287 | 177 | 287 | ||
| EG003 | Citalopram 40 mg/Day | Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11. | 6 | 282 | 147 | 282 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA (15.1) | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Asthma | Immune system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Bipolar I disorder | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Diverticulitis | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Electrocardiogram ST segment abnormal | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Gastric disorder | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA (15.1) | Systematic Assessment |
| |
| Ilium fracture | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Migraine with aura | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Somnolence | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Traumatic renal injury | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Wrist fracture | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abscess Neck | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Abscess Oral | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Obstructive Airways Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Somnolence | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (15.1) | Systematic Assessment |
|
All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study.
Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suresh Durgam, MD Clinical Asset Lead for Vilazodone - Senior Director - Clinical Development | Forest Research Institute | 201 427-8000 | 8172 | suresh.durgam@frx.com |
| 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 |
|---|---|
| D000069503 | Vilazodone Hydrochloride |
| D015283 | Citalopram |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007211 | Indoles |
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
Not provided
Not provided
| ≥ 20-29 years |
|
| ≥ 30-39 years |
|
| ≥ 40-49 years |
|
| ≥ 50-59 years |
|
| ≥ 60 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
|
| 0.0034 |
P-value was adjusted for multiplicity. |
| Mean Difference (Final Values) |
| -2.82 |
| 2-Sided |
| 95 |
| -4.57 |
| -1.06 |
| No |
| Superiority or Other |
| Mixed-effect model | 0.0020 | P-value was provided for assay sensitivity. It was not adjusted for multiplicity. | Mean Difference (Final Values) | -2.74 | 2-Sided | 95 | -4.48 | -1.00 | No | Superiority or Other |
| OG002 | Vilazodone 40 mg/Day | Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days. |
| OG003 | Citalopram 40 mg/Day | Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11. |
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Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11. |
| OG002 | Vilazodone 40 mg/Day | Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days |
| OG003 | Citalopram 40 mg/Day | Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11. |
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