Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder Depression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1162
Healthy volunteers: no

Brief summary:
The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed dose levels of vilazodone compared to placebo in patients with major depressive disorder.

Detailed description:

Arms:
arm 1: Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. arm 2: Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11. arm 3: Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days. arm 4: Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.

Interventions: intervention 1: Vilazodone intervention 2: Placebo to citalopram intervention 3: Placebo to vilazodone intervention 4: Citalopram
Intervention descriptions: intervention 1: Vilazodone was supplied as film-coated tablets. intervention 2: Placebo to citalopram was supplied as a capsule. intervention 3: Placebo to vilazodone was supplied as film-coated tablets. intervention 4: Citalopram was supplied as encapsulated tablets.

Protocol document: