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The purpose of this study was to further characterize the efficacy, safety, and tolerability of a single fixed dose level of vilazodone compared to placebo in patients with major depressive disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose-matched placebo | Placebo Comparator | Participants received dose-matched placebo orally once daily for 9 weeks. |
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| Vilazodone | Experimental | Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dose-matched placebo | Drug | Dose-matched placebo was supplied as tablets. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8 | The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Patients were rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. 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 on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement. | Baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8 | The CGI-S is a clinician-rated scale for assessing the severity of the participant's current state of mental illness compared with a patient population with major depressive disorder. The clinician responded to the following question "Considering your total clinical experience with this population, how mentally ill is the participant at this time?" on a 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. The scale ranges from 1 to 7. A higher score indicates more severe mental illness. A negative change score indicates improvement. |
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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 any:
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| Name | Affiliation | Role |
|---|---|---|
| Carl Gommoll, MS | Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 009 | Beverly Hills | California | 90210 | United States | ||
| Forest Investigative Site 003 |
| 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. | |
| 25470094 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose-matched Placebo | Participants received dose-matched placebo orally once daily for 9 weeks. |
| FG001 | Vilazodone | Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Vilazodone |
| Drug |
Vilazodone was supplied as tablets. |
|
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| Baseline to Week 8 |
| Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response Rate | The MADRS Sustained response rate is defined as a MÅDRS total score ≤ 12 for at least the last 2 consecutive visits during the double-blind treatment period. | Baseline to Week 8 |
| Encino |
| California |
| 91316 |
| United States |
| Forest Investigative Site 010 | New Port Beach | California | 92660 | United States |
| Forest Investigative Site 005 | Jacksonville | Florida | 32216 | United States |
| Forest Investigative Site 004 | Orlando | Florida | 32806 | United States |
| Forest Investigative Site 012 | Atlanta | Georgia | 30328 | United States |
| Forest Investigative Site 001 | Baltimore | Maryland | 21285 | United States |
| Forest Investigative Site 002 | Dayton | Ohio | 45417 | United States |
| Forest Investigative Site 011 | Philadelphia | Pennsylvania | 19104 | United States |
| Forest Investigative Site 015 | Lincoln | Rhode Island | 02865 | United States |
| Forest Investigative Site 008 | Memphis | Tennessee | 38119 | United States |
| Forest Investigative Site 016 | San Antonio | Texas | 78229 | United States |
| Forest Investigative Site 006 | Bellevue | Washington | 98007 | United States |
| Forest Investigative Site 013 | Seattle | Washington | 98104 | United States |
| Croft HA, Pomara N, Gommoll C, Chen D, Nunez R, Mathews M. Efficacy and safety of vilazodone in major depressive disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2014 Nov;75(11):e1291-8. doi: 10.4088/JCP.14m08992. |
| 25396353 | Derived | Citrome L, Gommoll CP, Tang X, Nunez R, Mathews M. Evaluating the efficacy of vilazodone in achieving remission in patients with major depressive disorder: post-hoc analyses of a phase IV trial. Int Clin Psychopharmacol. 2015 Mar;30(2):75-81. doi: 10.1097/YIC.0000000000000056. |
| COMPLETED |
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| NOT COMPLETED |
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Safety population: All randomized participants who received at least 1 dose of double-blind investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose-matched Placebo | Participants received dose-matched placebo orally once daily for 9 weeks. |
| BG001 | Vilazodone | Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days. |
| BG002 | 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 |
| |||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Body mass index | Mean | Standard Deviation | kg/m^2 |
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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 the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8 | The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Patients were rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. 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 on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement. | Intent-to-treat population: All randomized participants who received at least 1 dose of double-blind investigational product 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 8 |
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| Secondary | Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8 | The CGI-S is a clinician-rated scale for assessing the severity of the participant's current state of mental illness compared with a patient population with major depressive disorder. The clinician responded to the following question "Considering your total clinical experience with this population, how mentally ill is the participant at this time?" on a 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. The scale ranges from 1 to 7. A higher score indicates more severe mental illness. A negative change score indicates improvement. | Intent-to-treat population: All randomized participants who received at least 1 dose of double-blind investigational product 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 8 |
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| Secondary | Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response Rate | The MADRS Sustained response rate is defined as a MÅDRS total score ≤ 12 for at least the last 2 consecutive visits during the double-blind treatment period. | Intent-to-treat population: All randomized participants who received at least 1 dose of double-blind investigational product 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 8 |
|
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Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose-matched Placebo | Participants received dose-matched placebo orally once daily for 9 weeks. | 2 | 253 | 78 | 253 | ||
| EG001 | Vilazodone | Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days. | 3 | 255 | 149 | 255 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-cardiac chest pain | General disorders | MedDRA (15.1) | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
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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 | |
|---|---|---|---|---|
| Carl Gommoll | Forest Research Institute, Inc. | 201 427-8000 |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000069503 | Vilazodone Hydrochloride |
| 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 |
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| ≥ 20-29 |
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| ≥ 30-39 |
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| ≥ 40-49 |
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| ≥ 50-59 |
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| ≥ 60 |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| Asian |
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| American Indian or Alaska Native |
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| Native Hawaiian or Other Pacific Islander |
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| Other |
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