Safety and Efficacy of Vilazodone in Major Depressive Disorder

Major Depressive Disorder Clinical Trial

— VLZ-MD-01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01473381
• Other study ID #: VLZ-MD-01
• Status: Completed
• Phase: Phase 4
• First received: November 14, 2011
• Last updated: August 6, 2014
• Start date: December 2011
• Est. completion date: June 2013

Study information

• Verified date: August 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 evaluate the efficacy, safety, and tolerability of 2 fixed dose levels of vilazodone compared to placebo in patients with major depressive disorder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1162
• Est. completion date: June 2013
• Est. primary completion date: June 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:
• Vilazodone
Vilazodone was supplied as film-coated tablets.
• Placebo to citalopram
Placebo to citalopram was supplied as a capsule.
• Placebo to vilazodone
Placebo to vilazodone was supplied as film-coated tablets.
• Citalopram
Citalopram was supplied as encapsulated tablets.

Locations

Country	Name	City	State
United States	Forest Investigative Site 010	Albuquerque	New Mexico
United States	Forest Investigative Site 011	Albuquerque	New Mexico
United States	Forest Investigative Site 014	Allentown	Pennsylvania
United States	Forest Investigative Site 060	Atlanta	Georgia
United States	Forest Investigative Site 013	Austin	Texas
United States	Forest Investigative Site 020	Baltimore	Maryland
United States	Forest Investigative Site 059	Bellevue	Washington
United States	Forest Investigative Site 036	Birmingham	Alabama
United States	Forest Investigative Site 031	Boston	Massachusetts
United States	Forest Investigative Site 049	Bridgeville	Pennsylvania
United States	Forest Investigative Site 004	Brooklyn	New York
United States	Forest Investigative Site 007	Cedarhurst	New York
United States	Forest Investigative Site 029	Cerritos	California
United States	Forest Investigative Site 037	Chicago	Illinois
United States	Forest Investigative Site 050	Chicago	Illinois
United States	Forest Investigative Site 039	Cincinnati	Ohio
United States	Forest Investigative Site 002	Costa Mesa	California
United States	Forest Investigative Site 034	Cromwell	Connecticut
United States	Forest Investigative Site 021	Dallas	Texas
United States	Forest Investigative Site 016	Dothan	Alabama
United States	Forest Investigative Site 027	Fayetteville	Arkansas
United States	Forest Investigative Site 038	Fort Myers	Florida
United States	Forest Investigative Site 018	Gainsville	Florida
United States	Forest Investigative Site 055	Hallandale Beach	Florida
United States	Forest Investigative Site 040	Indianapolis	Indiana
United States	Forest Investigative Site 063	Jacksonville	Florida
United States	Forest Investigative Site 012	Lafayette	Indiana
United States	Forest Investigative Site 061	Las Vegas	Nevada
United States	Forest Investigative Site 064	Memphis	Tennessee
United States	Forest Investigative Site 035	Miami	Florida
United States	Forest Investigative Site 052	Middleton	Wisconsin
United States	Forest Investigative Site 056	Milwaukee	Wisconsin
United States	Forest Investigative Site 019	Murrieta	California
United States	Forest Investigative Site 047	New York	New York
United States	Forest Investigative Site 058	New York City	New York
United States	Forest Investigative Site 025	Oceanside	California
United States	Forest Investigative Site 042	Oklahoma City	Oklahoma
United States	Forest Investigative Site 048	Oklahoma City	Oklahoma
United States	Forest Investigative Site 043	Orange	California
United States	Forest Investigative Site 030	Orlando	Florida
United States	Forest Investigative Site 062	Orlando	Florida
United States	Forest Investigative Site 045	Pembroke Pines	Florida
United States	Forest Investigative Site 066	Portland	Oregon
United States	Forest Investigative Site 053	Prairie Village	Kansas
United States	Forest Investigative Site 003	Redlands	California
United States	Forest Investigative Site 033	Scottsdale	Arizona
United States	Forest Investigative Site 065	Seattle	Washington
United States	Forest Investigative Site 046	Sherman Oaks	California
United States	Forest Investigative Site 054	Spokane	Washington
United States	Forest Investigative Site 051	Tampa	Florida
United States	Forest Investigative Site 057	Upland	California
United States	Forest Investigative Site 032	West Palm Beach	Florida
United States	Forest Investigative Site 024	Willingboro	New Jersey
United States	Forest Investigative Site 022	Winter Park	Florida

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 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	No
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.	Baseline to Week 10	No
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.	Baseline to Week 10	No