NCT03610048

A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)

A Phase 3b Extension Study of Adjunctive ALKS 5461 in the Treatment of Refractory Major Depressive Disorder

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive treatment for refractory MDD.

Conditions

• Refractory Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	ALKS 5461	samidorphan + buprenorphine administered sublingually

Timeline

• Start date: 2018-08-09
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2018-08-01
• Last updated: 2021-07-16
• Results posted: 2021-07-16

Locations

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

Regulatory

• FDA-regulated drug study