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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00285376
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : February 21, 2008
Information provided by:
Genaissance Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: vilazodone Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 410 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
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

Primary Outcome Measures :
  1. MADRS [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. HAM-D [ Time Frame: 8 weeks ]
  2. CGI [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00285376

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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
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Study Director: Carol Reed, M.D. Genaissance Pharmaceuticals
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Carol Reed, MD, Genaissance Pharmaceuticals Identifier: NCT00285376    
Other Study ID Numbers: GNSC-04-DP-02
First Posted: February 2, 2006    Key Record Dates
Last Update Posted: February 21, 2008
Last Verified: February 2008
Keywords provided by Genaissance Pharmaceuticals:
Depression. Genetics, Pharmacogenetics
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Vilazodone Hydrochloride
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists