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

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

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

Summary

Timeline

Publications

Drugs

Indications