NCT00644358

A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder (MDD)

A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 616 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This open label 52-week clinical trial is designed to assess the safety and tolerability of vilazodone and to analyze genetic markers of response to vilazodone in adult patients diagnosed with MDD. This study will enroll approximately 600 patients.

Detailed description

Patients will be enrolled at approximately 40 US investigative sites and receive vilazodone for 52 weeks of open label treatment. Safety measurements will include adverse events, vital signs, laboratory, ophthalmologic exams, Changes in Sexual Function Questionnaire (CSFQ) scale and electrocardiogram (ECG) findings collected over the course of the treatment period. Effectiveness measurements will be done at baseline and each visit until week 52 or end-of-treatment. A deoxyribonucleic acid (DNA) sample will be collected for genetic analysis related to response to vilazodone.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	vilazodone	titration to 40 milligrams (mg) every day (qd) for 1 year

Timeline

• Start date: 2007-12-31
• Primary completion: 2009-05-31
• Completion: 2009-05-31
• First posted: 2008-03-26
• Last updated: 2017-09-25
• Results posted: 2017-09-25

Locations

38 sites across 1 country: United States