drugset / Trial / NCT02158533

A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study

NCT02158533 ↗

Phase 3 Completed 385 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 p = 0.109; Least squares mean difference -1.8 (95% CI -4.1 to 0.4) NCT02158533 ↗

registry p = 0.975; Least squares mean difference 0.0 (95% CI -2.3 to 2.3) NCT02158533 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject ALKS 5461 Unknown — Other