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

February 12, 2008 updated by: Genaissance Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

410

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • 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
        • Pharmacology Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Atlanta Institute of Medicine & Research
      • Marietta, Georgia, United States, 30060
        • Atlanta Institute of Medicine & Research
    • Michigan
      • Farmington Hills, Michigan, United States, 48336
        • Summit Research Network (Michigan), Inc.
      • Flint, Michigan, United States, 48507
        • Summit Research Network (Michigan), Inc.
    • New York
      • Brooklyn, New York, United States, 11235
        • Social Psychiatry Research Institute
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Research Network (Oregon) Inc.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-3309
        • University of Pennsylvania Department of Psychiatry Mood and Anxiety Disorders Section
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Southeast Health Consultants, LLC
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah health Services Center Dept. of Psychiatry Mood and Anxiety Disorders
    • Washington
      • Bellevue, Washington, United States, 98004
        • Northwest Clinical Research Center
      • Seattle, Washington, United States, 98104
        • Summit Research Network (Seattle) Llc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: vilazodone
titration to 40mg tablets qd for 8 weeks
Other Names:
  • EMD 68843, SB-659746
Experimental: 1
vilazodone
Drug: vilazodone
titration to 40mg tablets qd for 8 weeks
Other Names:
  • EMD 68843, SB-659746

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MADRS
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
HAM-D
Time Frame: 8 weeks
8 weeks
CGI
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genaissance Pharmaceuticals

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

January 31, 2006

First Submitted That Met QC Criteria

January 31, 2006

First Posted (Estimate)

February 2, 2006

Study Record Updates

Last Update Posted (Estimate)

February 21, 2008

Last Update Submitted That Met QC Criteria

February 12, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GNSC-04-DP-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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