A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)

Phase 2 Completed 142 enrolled Alkermes, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant therapy.

Timeline

Start: 2011-12
Primary completion: 2013-03
Completion: 2013-03

Outcome

Met primary endpoint

paper Compared with the placebo group, there were significantly greater improvements in the 2/2 dosage group across the three depression outcome measures PMID 26869247 ↗

Publications

Results Fava M, Memisoglu A, Thase ME, Bodkin JA, Trivedi MH, de Somer M, Du Y, Leigh-Pemberton R, DiPetrillo L, Silverman B, Ehrich E. Opioid Modulation With Buprenorphine/Samidorphan as Adjunctive Treatment for Inadequate Response to Antidepressants: A Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2016 May 1;173(5):499-508. doi: 10.1176/appi.ajp.2015.15070921. Epub 2016 Feb 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Buprenorphine	Other / unclassified	2 mg	—
Subject	Buprenorphine	Other / unclassified	8 mg	—
Subject	Samidorphan	Small molecule	2 mg	—
Subject	Samidorphan	Small molecule	8 mg	—