Safety, Efficacy and Tolerability of Vilazodone in Major Depressive Disorder
Status: | Completed |
---|---|
Conditions: | Depression, Major Depression Disorder (MDD) |
Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | November 2011 |
End Date: | May 2013 |
Contact: | Sandra Beaird, PhD |
Email: | info@forestpharm.com |
Phone: | 1-800-678-1605 |
A Double-Blind, Placebo-Controlled, Fixed-Dose Study of Vilazodone in Patients With Major Depressive Disorder
The purpose of this study is further characterize the efficacy, safety and tolerability of a
single fixed dose level of vilazodone compared to placebo in patients with major depressive
disorder.
Inclusion Criteria:
- Men and women, 18-70 years of age
- Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
- The patient's current major depressive episode must be at least 8 weeks and no longer
than 12 months in duration
Exclusion Criteria:
- Women who are pregnant, women who will be breastfeeding during the study, and women
of childbearing potential who are not practicing a reliable method of birth control
- Patients with a history of meeting DSM-IV-TR criteria for:
- any manic, hypomanic or mixed episode, including bipolar disorder and
substance-induced manic, hypomanic, or mixed episode;
- any depressive episode with psychotic or catatonic features;
- panic disorder with or without agoraphobia;
- obsessive-compulsive disorder;
- Schizophrenia, schizoaffective, or other psychotic disorder;
- bulimia or anorexia nervosa;
- presence of borderline personality disorder or antisocial personality disorder;
- mental retardation, dementia, amnesia, or other cognitive disorders
- Patients who are considered a suicide risk
We found this trial at
14
sites
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