drugset / Trial / NCT02694328
A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects with schizophrenia.
Timeline
- Start
- 2016-03-02
- Primary completion
- 2018-11-07
- Completion
- 2018-11-07
Outcome
Met primary endpoint
registry analysis (superiority test); ALKS 3831; p = 0.003; Least Squares Mean Difference -2.38 (95% CI -3.88 to -0.88); NCT02694328 ↗
registry analysis (superiority test); Olanzapine vs ALKS 3831; p = 0.003; Risk Difference (RD) -13.7 (95% CI -22.8 to -4.6); NCT02694328 ↗
Publications
- Correll CU, Stein E, Graham C, DiPetrillo L, Akerman S, Stanford AD, Jiang Y, Yagoda S, McDonnell D, Hopkinson C. Reduction in Multiple Cardiometabolic Risk Factors With Combined Olanzapine/Samidorphan Compared With Olanzapine: Post Hoc Analyses From a 24-Week Phase 3 Study. Schizophr Bull. 2023 Mar 15;49(2):454-463. doi: 10.1093/schbul/sbac144.
- Meyer JM, Simmons A, Jiang Y, Graham C, Yagoda S, McDonnell D. Olanzapine/samidorphan combination consistently mitigates weight gain across various subgroups of patients. CNS Spectr. 2023 Aug;28(4):478-481. doi: 10.1017/S1092852922000967. Epub 2022 Oct 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Olanzapine | Small molecule | — | — |
| Subject | Samidorphan | Small molecule | — | — |