A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study

Summary

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

Timeline

Start

2014-07

Primary completion

2016-09

Completion

2016-10

Outcome

Mixed primary results

registry analysis (superiority test); Placebo S1 vs ALKS 5461 2mg/2mg S1 vs Placebo S2 vs ALKS 5461 2mg/2mg S2; p = 0.018; Least Squares Mean Difference -1.5 (95% CI -2.7 to -0.3) NCT02218008 ↗

registry analysis (superiority test); Placebo S1 vs ALKS 5461 2mg/2mg S1 vs Placebo S2 vs ALKS 5461 2mg/2mg S2; p = 0.026; Least Squares Mean Difference -1.9 (95% CI -3.6 to -0.2) NCT02218008 ↗

registry analysis (superiority test); Placebo S1 vs ALKS 5461 2mg/2mg S1 vs Placebo S2 vs ALKS 5461 2mg/2mg S2; p = 0.076; Least Squares Mean Difference -1.7 (95% CI -3.6 to 0.2) NCT02218008 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ALKS 5461	Unknown	—	Other

Indications