drugset / Trial / NCT02634346
A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation of schizophrenia.
Timeline
- Start
- 2015-12
- Primary completion
- 2017-05-25
- Completion
- 2017-06-07
Outcome
Met primary endpoint
registry analysis (superiority test); ALKS 3831 vs Placebo; p <0.001; Least square mean difference -6.4 (95% CI -10.0 to -2.8); NCT02634346 ↗
release “ENLIGHTEN-1 met its prespecified primary endpoint” alkermes.com ↗
Publications
- McIntyre RS, Matthews DM, Arevalo C, McDonnell D, Correll CU. The Efficacy of Olanzapine/Samidorphan on Negative Symptoms: A Post Hoc Analysis of 56-Week Treatment in Patients With Schizophrenia. J Clin Psychiatry. 2026 Mar 9;87(2):25m16170. doi: 10.4088/JCP.25m16170.
- Potkin SG, Kunovac J, Silverman BL, Simmons A, Jiang Y, DiPetrillo L, McDonnell D. Efficacy and Safety of a Combination of Olanzapine and Samidorphan in Adult Patients With an Acute Exacerbation of Schizophrenia: Outcomes From the Randomized, Phase 3 ENLIGHTEN-1 Study. J Clin Psychiatry. 2020 Mar 3;81(2):19m12769. doi: 10.4088/JCP.19m12769.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olanzapine | Small molecule | — | — |
| Subject | Samidorphan | Small molecule | — | — |