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Sponsored by: |
Genaissance Pharmaceuticals |
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Information provided by: | Genaissance Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00285376 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
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 |
---|---|
1: Experimental
vilazodone
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Drug: vilazodone
titration to 40mg tablets qd for 8 weeks
|
2: Placebo Comparator |
Drug: vilazodone
titration to 40mg tablets qd for 8 weeks
|
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Pharmacology Research Institute | |
Newport Beach, California, United States, 92660 | |
Pharmacology Research Institute | |
Los Alamitos, California, United States, 90720 | |
Pharmacology Research Institute | |
Riverside, California, United States, 92506 | |
Pharmacology Research Institute | |
Northridge, California, United States, 91324 | |
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 |
Study Director: | Carol Reed, M.D. | Genaissance Pharmaceuticals |
Responsible Party: | Genaissance Pharmaceuticals ( Carol Reed, MD ) |
Study ID Numbers: | GNSC-04-DP-02 |
Study First Received: | January 31, 2006 |
Last Updated: | February 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00285376 |
Health Authority: | United States: Food and Drug Administration |
Depression. Genetics, Pharmacogenetics |
Depression Mental Disorders Mood Disorders |
Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |
Pathologic Processes Disease |