Conditions: Major Depressive Disorder
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 616
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Vilazodone titrated up to 40 mg/day for 1 year.

Interventions: intervention 1: vilazodone
Intervention descriptions: intervention 1: titration to 40 milligrams (mg) every day (qd) for 1 year

Protocol document: