Effectiveness Study of Vilazodone to Treat Depression and to Discover Genetic Markers Associated With Response
Depressive Disorder, Major
About this trial
This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Depression. Genetics, Pharmacogenetics
Eligibility Criteria
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.
Sites / Locations
- Pharmacology Research Institute
- Pharmacology Research Institute
- Pharmacology Research Institute
- Pharmacology Research Institute
- Atlanta Institute of Medicine & Research
- Atlanta Institute of Medicine & Research
- Summit Research Network (Michigan), Inc.
- Summit Research Network (Michigan), Inc.
- Social Psychiatry Research Institute
- Summit Research Network (Oregon) Inc.
- University of Pennsylvania Department of Psychiatry Mood and Anxiety Disorders Section
- Southeast Health Consultants, LLC
- University of Utah health Services Center Dept. of Psychiatry Mood and Anxiety Disorders
- Northwest Clinical Research Center
- Summit Research Network (Seattle) LLC
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
1
2
vilazodone