Effectiveness Study of Vilazodone to Treat Depression and to Discover Genetic Markers Associated With Response

Depressive Disorder, Major Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo Controlled Study Assessing the Efficacy and Safety of Vilazodone and Discovering Genetic Markers Associated With Response in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00285376
• Other study ID #: GNSC-04-DP-02
• Status: Completed
• Phase: Phase 3
• First received: January 31, 2006
• Last updated: February 12, 2008
• Start date: February 2006
• Est. completion date: May 2007

Study information

• Verified date: February 2008
• Source: Genaissance Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is designed to determine the safety and effectiveness of vilazodone for major depressive disorder and to discover genetic markers associated with response. This study will enroll approximately 400 patients.

Description:

This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is designed to assess the efficacy and safety of vilazodone and to discover genetic markers of treatment response associated with vilazodone use in adult patients diagnosed with MDD by the DSM-IV-TR criteria. This study will enroll approximately 400 patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female patients 18-65 years of age, inclusive.

• A diagnosis of MDD, single episode or recurrent, according to DSM-IV-TR (296.2/296.3) with a current Major Depressive Episode of less than two year's duration with a minimum duration of at least 4 weeks.

• HAM-D score = 22.

• HAM-D item 1 (depressed mood) score = 2.

• Patients must be able to provide written informed consent to participate before beginning any trial related activities.

• Patients must be able to speak, read and understand English and possess the ability to respond to questions and follow simple instructions.

Exclusion Criteria:

• A current (or within 6 months prior to the Screening Visit) Axis I disorder of Post Traumatic Stress Disorder, Eating Disorder, Obsessive Compulsive Disorder (Generalized Anxiety Disorder, Social Phobia or Simple Phobia will be allowed).

• A history of schizophrenia, schizoaffective disorder or bipolar I or II disorder (with a history of hypomanic or manic episodes).

• DSM-IV-TR criteria for substance abuse (alcohol or drugs) within 3 months prior to Screening Visit or substance dependence within 6 months prior to the Screening Visit.

• Criteria for any of the following DSM-IV-TR MDD Specifiers: [a] With Catatonic Features; [b] With Postpartum Onset; [c] With Seasonal Pattern.

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• vilazodone
titration to 40mg tablets qd for 8 weeks

Locations

Country	Name	City	State
United States	Atlanta Institute of Medicine & Research	Atlanta	Georgia
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Social Psychiatry Research Institute	Brooklyn	New York
United States	Southeast Health Consultants, LLC	Charleston	South Carolina
United States	Summit Research Network (Michigan), Inc.	Farmington Hills	Michigan
United States	Summit Research Network (Michigan), Inc.	Flint	Michigan
United States	Pharmacology Research Institute	Los Alamitos	California
United States	Atlanta Institute of Medicine & Research	Marietta	Georgia
United States	Pharmacology Research Institute	Newport Beach	California
United States	Pharmacology Research Institute	Northridge	California
United States	University of Pennsylvania Department of Psychiatry Mood and Anxiety Disorders Section	Philadelphia	Pennsylvania
United States	Summit Research Network (Oregon) Inc.	Portland	Oregon
United States	Pharmacology Research Institute	Riverside	California
United States	University of Utah health Services Center Dept. of Psychiatry Mood and Anxiety Disorders	Salt Lake City	Utah
United States	Summit Research Network (Seattle) LLC	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Genaissance Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MADRS		8 weeks	No
Secondary	HAM-D		8 weeks	No
Secondary	CGI		8 weeks	No