Depressive Disorder, Major Clinical Trial
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
Verified date | February 2008 |
Source | Genaissance Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 410 |
Est. completion date | May 2007 |
Est. primary completion date | May 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Atlanta Institute of Medicine & Research | Atlanta | Georgia |
United States | Northwest Clinical Research Center | Bellevue | Washington |
United States | Social Psychiatry Research Institute | Brooklyn | New York |
United States | Southeast Health Consultants, LLC | Charleston | South Carolina |
United States | Summit Research Network (Michigan), Inc. | Farmington Hills | Michigan |
United States | Summit Research Network (Michigan), Inc. | Flint | Michigan |
United States | Pharmacology Research Institute | Los Alamitos | California |
United States | Atlanta Institute of Medicine & Research | Marietta | Georgia |
United States | Pharmacology Research Institute | Newport Beach | California |
United States | Pharmacology Research Institute | Northridge | California |
United States | University of Pennsylvania Department of Psychiatry Mood and Anxiety Disorders Section | Philadelphia | Pennsylvania |
United States | Summit Research Network (Oregon) Inc. | Portland | Oregon |
United States | Pharmacology Research Institute | Riverside | California |
United States | University of Utah health Services Center Dept. of Psychiatry Mood and Anxiety Disorders | Salt Lake City | Utah |
United States | Summit Research Network (Seattle) LLC | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Genaissance Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MADRS | 8 weeks | No | |
Secondary | HAM-D | 8 weeks | No | |
Secondary | CGI | 8 weeks | No |
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