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

This study has been completed.
Sponsor:
Information provided by:
Genaissance Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00285376
First received: January 31, 2006
Last updated: February 12, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Depressive Disorder, Major
Drug: vilazodone
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Genaissance Pharmaceuticals:

Primary Outcome Measures:
  • MADRS [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HAM-D [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • CGI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 410
Study Start Date: February 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
vilazodone
Drug: vilazodone
titration to 40mg tablets qd for 8 weeks
Other Name: EMD 68843, SB-659746
Placebo Comparator: 2 Drug: vilazodone
titration to 40mg tablets qd for 8 weeks
Other Name: EMD 68843, SB-659746

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285376

Locations
United States, California
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
Pharmacology Research Institute
Newport Beach, California, United States, 92660
Pharmacology Research Institute
Northridge, California, United States, 91324
Pharmacology Research Institute
Riverside, California, United States, 92506
United States, Georgia
Atlanta Institute of Medicine & Research
Atlanta, Georgia, United States, 30328
Atlanta Institute of Medicine & Research
Marietta, Georgia, United States, 30060
United States, Michigan
Summit Research Network (Michigan), Inc.
Farmington Hills, Michigan, United States, 48336
Summit Research Network (Michigan), Inc.
Flint, Michigan, United States, 48507
United States, New York
Social Psychiatry Research Institute
Brooklyn, New York, United States, 11235
United States, Oregon
Summit Research Network (Oregon) Inc.
Portland, Oregon, United States, 97210
United States, Pennsylvania
University of Pennsylvania Department of Psychiatry Mood and Anxiety Disorders Section
Philadelphia, Pennsylvania, United States, 19104-3309
United States, South Carolina
Southeast Health Consultants, LLC
Charleston, South Carolina, United States, 29407
United States, Utah
University of Utah health Services Center Dept. of Psychiatry Mood and Anxiety Disorders
Salt Lake City, Utah, United States, 84132
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98004
Summit Research Network (Seattle) LLC
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Genaissance Pharmaceuticals
Investigators
Study Director: Carol Reed, M.D. Genaissance Pharmaceuticals
  More Information

No publications provided by Genaissance Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carol Reed, MD, Genaissance Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00285376     History of Changes
Other Study ID Numbers: GNSC-04-DP-02
Study First Received: January 31, 2006
Last Updated: February 12, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Genaissance Pharmaceuticals:
Depression. Genetics, Pharmacogenetics

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 17, 2014