Safety and Efficacy of Vilazodone in Major Depressive Disorder

Study Overview
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Brief Summary
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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.

Official Title
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A Double-blind, Placebo- and Active-controlled, Fixed-dose Study of Vilazodone in Patients With Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Vilazodone
* Drug: Placebo to citalopram
* Drug: Placebo to vilazodone
* Drug: Citalopram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, 18-70 years of age. Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder. The patient's current major depressive episode must be at least 8 weeks and no longer than 12 months in duration. 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 manic, hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic, or mixed episode Any depressive episode with psychotic or catatonic features Panic disorder with or without agoraphobia Obsessive-compulsive disorder Schizophrenia, schizoaffective, or other psychotic disorder Bulimia or anorexia nervosa Presence of borderline personality disorder or antisocial personality disorder Mental retardation, dementia, amnesia, or other cognitive disorders. Patients who are considered a suicide risk.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. | Drug: Placebo to citalopram<br>* Placebo to citalopram was supplied as a capsule.<br>* Other names: Celexa;Drug: Placebo to vilazodone<br>* Placebo to vilazodone was supplied as film-coated tablets.<br>|
| Experimental: Vilazodone 20 mg/day<br>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. | Drug: Vilazodone<br>* Vilazodone was supplied as film-coated tablets.<br>* Other names: Viibryd;Drug: Placebo to citalopram<br>* Placebo to citalopram was supplied as a capsule.<br>* Other names: Celexa;Drug: Placebo to vilazodone<br>* Placebo to vilazodone was supplied as film-coated tablets.<br>|
| Experimental: Vilazodone 40 mg/day<br>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. | Drug: Vilazodone<br>* Vilazodone was supplied as film-coated tablets.<br>* Other names: Viibryd;Drug: Placebo to citalopram<br>* Placebo to citalopram was supplied as a capsule.<br>* Other names: Celexa;Drug: Placebo to vilazodone<br>* Placebo to vilazodone was supplied as film-coated tablets.<br>|
| Active Comparator: Citalopram 40 mg/day<br>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. | Drug: Placebo to vilazodone<br>* Placebo to vilazodone was supplied as film-coated tablets.<br>Drug: Citalopram<br>* Citalopram was supplied as encapsulated tablets.<br>* Other names: Celexa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depressive Disorder, Depression