Conditions: Major Depressive Disorder
Keywords: Major depressive disorder Depression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 518
Healthy volunteers: no

Brief summary:
The purpose of this study was to further characterize the efficacy, safety, and tolerability of a single fixed dose level of vilazodone compared to placebo in patients with major depressive disorder.

Detailed description:

Arms:
arm 1: Participants received dose-matched placebo orally once daily for 9 weeks. arm 2: Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.

Interventions: intervention 1: Dose-matched placebo intervention 2: Vilazodone
Intervention descriptions: intervention 1: Dose-matched placebo was supplied as tablets. intervention 2: Vilazodone was supplied as tablets.

Protocol document: