drugset / Trial / NCT02158546

A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study

NCT02158546 ↗

Phase 3 Completed 447 enrolled Alkermes, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will evaluate the efficacy and safety of ALKS 5461.

Timeline

Start
2014-05
Primary completion
2015-12
Completion
2015-12

Outcome

Missed primary endpoint

registry analysis (superiority test); ALKS 5461 2mg/2mg vs Placebo; p = 0.782; Least square means difference -0.3 (95% CI -2.1 to 1.6); NCT02158546 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject ALKS 5461 Unknown — Other