Conditions: Depressive Disorder, Major
Keywords: Fetzima Relapse-prevention Placebo-controlled
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 644
Healthy volunteers: no

Brief summary:
This study evaluates the efficacy, safety and tolerability of levomilnacipran extended-release (ER) compared with placebo in the prevention of depression relapse in major depressive disorder (MDD).

Detailed description:

Arms:
arm 1: FETZIMA® (levomilnacipran extended release \[ER\]) taken orally during flexible dose titration up to 40, 80 or 120 mg once daily in 8-week run-in period followed by fixed dose of 40, 80 or 120 mg once daily in 12-week stabilization period. arm 2: Dose-matched placebo taken orally once daily for 26 weeks during double-blind treatment period. arm 3: FETZIMA® (levomilnacipran ER) taken orally at fixed dose of 40, 80 or 120 mg once daily for 26 weeks during double-blind treatment period.

Interventions: intervention 1: Levomilnacipran ER intervention 2: Placebo
Intervention descriptions: intervention 1: Levomilnacipran ER taken orally at 40, 80 or 120 mg once daily. intervention 2: Dose-matched placebo taken orally once daily.

Protocol document: