NCT00683592

Randomized, Double-Blind, Placebo Controlled Study of Vilazodone's Efficacy, Safety, and Biomarkers of Response in Major Depressive Disorder (MDD)

A Randomized, Double-blind, Placebo Controlled Study Assessing the Efficacy and Safety of Vilazodone 40 mg qd and Evaluating Genetic Biomarkers Associated With Treatment Response in Patients With Major Depressive Disorder (MDD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 481 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is designed to assess the efficacy and safety of vilazodone and to evaluate genetic biomarkers of treatment response associated with vilazodone use in adult patients diagnosed with MDD by the DSM-IV-TR criteria.

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 evaluate genetic biomarkers of treatment response associated with vilazodone use in adult patients diagnosed with MDD by the DSM-IV-TR criteria. This study will enroll approximately 470 patients at approximately 10 clinical sites. Safety and efficacy will be assessed at each visit. A DNA sample will be collected and analyzed for response to vilazodone.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	vilazodone	titration to 40 mg tablets qd (once a day) for 8 weeks
DRUG	placebo	placebo

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-02-01
• Completion: 2009-03-01
• First posted: 2008-05-23
• Last updated: 2010-10-27
• Results posted: 2010-10-27

Locations

9 sites across 1 country: United States