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

Sponsor
Genaissance Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00285376
Collaborator
(none)
410
Enrollment
15
Locations
2
Arms
14.9
Duration (Months)
27.3
Patients Per Site
1.8
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
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 :
Feb 1, 2006
Actual Primary Completion Date :
May 1, 2007
Actual Study Completion Date :
May 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

vilazodone

Drug: vilazodone
titration to 40mg tablets qd for 8 weeks
Other Names:
  • EMD 68843, SB-659746

    		•
    Placebo Comparator: 2

    Drug: vilazodone
    titration to 40mg tablets qd for 8 weeks
    Other Names:
  • EMD 68843, SB-659746

    		•

    Outcome Measures

    Primary Outcome Measures

    1. MADRS [8 weeks]

    Secondary Outcome Measures

    1. HAM-D [8 weeks]

    2. CGI [8 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pharmacology Research Institute Los Alamitos California United States 90720
    2 Pharmacology Research Institute Newport Beach California United States 92660
    3 Pharmacology Research Institute Northridge California United States 91324
    4 Pharmacology Research Institute Riverside California United States 92506
    5 Atlanta Institute of Medicine & Research Atlanta Georgia United States 30328
    6 Atlanta Institute of Medicine & Research Marietta Georgia United States 30060
    7 Summit Research Network (Michigan), Inc. Farmington Hills Michigan United States 48336
    8 Summit Research Network (Michigan), Inc. Flint Michigan United States 48507
    9 Social Psychiatry Research Institute Brooklyn New York United States 11235
    10 Summit Research Network (Oregon) Inc. Portland Oregon United States 97210
    11 University of Pennsylvania Department of Psychiatry Mood and Anxiety Disorders Section Philadelphia Pennsylvania United States 19104-3309
    12 Southeast Health Consultants, LLC Charleston South Carolina United States 29407
    13 University of Utah health Services Center Dept. of Psychiatry Mood and Anxiety Disorders Salt Lake City Utah United States 84132
    14 Northwest Clinical Research Center Bellevue Washington United States 98004
    15 Summit Research Network (Seattle) LLC Seattle Washington United States 98104

    Sponsors and Collaborators

    • Genaissance Pharmaceuticals

    Investigators

    • Study Director: Carol Reed, M.D., Genaissance Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00285376
    Other Study ID Numbers:
    • GNSC-04-DP-02
    First Posted:
    Feb 2, 2006
    Last Update Posted:
    Feb 21, 2008
    Last Verified:
    Feb 1, 2008
    Keywords provided by , ,
    Depression. Genetics, Pharmacogenetics
    Additional relevant MeSH terms:
    Depressive Disorder
    Depression
    Depressive Disorder, Major
    Vilazodone Hydrochloride

    Study Results

    No Results Posted as of Feb 21, 2008