Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder

Phase 3 Completed 426 enrolled Alkermes, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will evaluate the effect of ALKS 3831 compared to olanzapine on body weight in young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in their illness

Timeline

Start: 2017-06-08
Primary completion: 2021-12-01
Completion: 2022-01-03

Outcome

Met primary endpoint

registry analysis (superiority test); ALKS 3831; p = .012; Least Squares Mean Difference -1.87 (95% CI -3.33 to -.41); ANCOVA NCT03187769 ↗

paper Percent weight change was significantly lower with OLZ/SAM versus olanzapine (4.91% vs 6.77%; least-squares mean [LSM] [SE] difference, -1.87% [0.75]; P = .012). PMID 36946605 ↗

Publications

Kahn RS, Kane JM, Correll CU, Arevalo C, Simmons A, Graham C, Yagoda S, Hu B, McDonnell D. Olanzapine/Samidorphan in Young Adults With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder Who Are Early in Their Illness: Results of the Randomized, Controlled ENLIGHTEN-Early Study. J Clin Psychiatry. 2023 Mar 22;84(3):22m14674. doi: 10.4088/JCP.22m14674.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Olanzapine	Small molecule	5 mg	Oral
Comparator	Olanzapine	Small molecule	20 mg	Oral
Subject	Samidorphan	Small molecule	10 mg	Oral