Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
ALKS 5461 extension in refractory MDD
NCT03610048Phase 3
Key facts
- Status
- Terminated
- Start
- Aug 2018
- Primary completion
- May 2020
- Countries
- 3
- Sponsor
- Alkermes
- Modality
- Orthosteric Ligands
- Conditions
- major depressive disorder (MDD)
01
Overview
Phase 3, open-label, single-arm trial of buprenorphine + samidorphan in major depressive disorder (MDD), sponsored by Alkermes. Primary endpoint: Treatment-emergent Adverse Events at 68 weeks. Started Aug 2018; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
ALKS 5461
Adjunctive ALKS 5461 (samidorphan + buprenorphine)
03
Who it enrols
Patients who completed study ALK5461-217, are willing to abide by contraception requirements, and do not pose a suicide risk or have a positive drug test.
04
Endpoints
Primary
Treatment-emergent Adverse Events
Beyond the preview
Go deeper on NCT03610048.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT03610048.