NCT03188185

A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)

A Phase 3b Efficacy and Safety Study of Adjunctive ALKS 5461 in Treatment Refractory Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in adults who have treatment refractory MDD.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	ALKS 5461	Samidorphan + buprenorphine, administered sublingually
DRUG	ALKS 5461 Placebo	Placebo tablet, administered sublingually

Timeline

• Start date: 2017-06-12
• Primary completion: 2020-02-26
• Completion: 2020-03-05
• First posted: 2017-06-15
• Last updated: 2021-04-08
• Results posted: 2021-03-15

Locations

35 sites across 3 countries: United States, Australia, Puerto Rico

Regulatory

• FDA-regulated drug study