drugset / Trial / NCT03188185
A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in adults who have treatment refractory MDD.
Timeline
- Start
- 2017-06-12
- Primary completion
- 2020-02-26
- Completion
- 2020-03-05
Outcome
Missed primary endpoint
registry p = 0.128; Least Squares Mean Difference -1.5 (95% CI -3.5 to 0.4) NCT03188185 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | — | Other |
| Subject | Samidorphan | Small molecule | — | Other |