Safety, Efficacy, and Tolerability of Vilazodone in Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01473394
• Other study ID #: VLZ-MD-03
• Status: Completed
• Phase: Phase 4
• First received: November 14, 2011
• Last updated: February 21, 2014
• Start date: December 2011
• Est. completion date: February 2013

Study information

• Verified date: February 2014
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 518
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Dose-matched placebo
Dose-matched placebo was supplied as tablets.
• Vilazodone
Vilazodone was supplied as tablets.

Locations

Country	Name	City	State
United States	Forest Investigative Site 012	Atlanta	Georgia
United States	Forest Investigative Site 001	Baltimore	Maryland
United States	Forest Investigative Site 006	Bellevue	Washington
United States	Forest Investigative Site 009	Beverly Hills	California
United States	Forest Investigative Site 002	Dayton	Ohio
United States	Forest Investigative Site 003	Encino	California
United States	Forest Investigative Site 005	Jacksonville	Florida
United States	Forest Investigative Site 015	Lincoln	Rhode Island
United States	Forest Investigative Site 008	Memphis	Tennessee
United States	Forest Investigative Site 010	New port Beach	California
United States	Forest Investigative Site 004	Orlando	Florida
United States	Forest Investigative Site 011	Philadelphia	Pennsylvania
United States	Forest Investigative Site 016	San Antonio	Texas
United States	Forest Investigative Site 013	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline to Week 8	No
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.	Baseline to Week 8	No
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.	Baseline to Week 8	No