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

Completed · Phase 3

Conditions studied: Depressive Disorder, Major

In brief

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.

Key facts

Study ID

NCT00285376

Run by

Genaissance Pharmaceuticals

People needed

410

Starts

2006-02-01

Expected to finish

2007-05-01

Last updated by the study team

2008-02-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pharmacology Research Institute — Los Alamitos, California, United States
• Pharmacology Research Institute — Newport Beach, California, United States
• Pharmacology Research Institute — Northridge, California, United States
• Pharmacology Research Institute — Riverside, California, United States
• Atlanta Institute of Medicine & Research — Atlanta, Georgia, United States
• Atlanta Institute of Medicine & Research — Marietta, Georgia, United States
• Summit Research Network (Michigan), Inc. — Farmington Hills, Michigan, United States
• Summit Research Network (Michigan), Inc. — Flint, Michigan, United States
• Social Psychiatry Research Institute — Brooklyn, New York, United States
• Summit Research Network (Oregon) Inc. — Portland, Oregon, United States
• University of Pennsylvania Department of Psychiatry Mood and Anxiety Disorders Section — Philadelphia, Pennsylvania, United States
• Southeast Health Consultants, LLC — Charleston, South Carolina, United States
• University of Utah health Services Center Dept. of Psychiatry Mood and Anxiety Disorders — Salt Lake City, Utah, United States
• Northwest Clinical Research Center — Bellevue, Washington, United States
• Summit Research Network (Seattle) LLC — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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