A Multicenter, Relapse Prevention Study With Levomilnacipran Extended Release (ER) in Participants With Major Depressive Disorder

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).

Timeline

Start

2014-11-18

Primary completion

2016-09-16

Completion

2016-09-16

Outcome

Met primary endpoint

registry analysis (superiority test); Double-Blind Placebo vs Double-Blind FETZIMA®; p = 0.0212; Hazard Ratio (HR) 0.56 (95% CI 0.33 to 0.92); Log Rank NCT02288325 ↗

Drugs

Indications