Status:
COMPLETED
Effectiveness Study of Vilazodone to Treat Depression and to Discover Genetic Markers Associated With Response
Lead Sponsor:
Genaissance Pharmaceuticals
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 approximat...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT00285376
Start Date
February 1 2006
End Date
May 1 2007
Last Update
February 21 2008
Active Locations (15)
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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