A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder

Phase 2 Completed 300 enrolled Alkermes, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This double-blind, randomized study will evaluate the efficacy, safety and tolerability of ALKS 3831 in subjects with schizophrenia and alcohol use disorder (AUD).

Timeline

Start: 2014-05
Primary completion: 2017-01-11
Completion: 2017-02-01

Outcome

Missed primary endpoint

registry analysis (superiority test); ALKS 3831 vs Olanzapine + Placebo; p = 0.746; Hazard Ratio (HR) 0.91 (95% CI 0.53 to 1.56); Log Rank NCT02161718 ↗

paper OLZ/SAM was not superior to olanzapine in the time to EEDS and was well tolerated in patients with schizophrenia and AUD. PMID 32160422 ↗

Publications

Results Brunette MF, Correll CU, O'Malley SS, McDonnell D, DiPetrillo L, Jiang Y, Simmons A, Silverman BL, Citrome L, Green AI. Olanzapine Plus Samidorphan (ALKS 3831) in Schizophrenia and Comorbid Alcohol Use Disorder: A Phase 2, Randomized Clinical Trial. J Clin Psychiatry. 2020 Mar 10;81(2):19m12786. doi: 10.4088/JCP.19m12786.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Samidorphan	Small molecule	10 mg	Oral
Comparator	Olanzapine	Small molecule	—	Oral