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

• Status: Terminated
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.

Criteria

Inclusion Criteria:

• Completed study ALK5461-217

• Be willing to abide by the contraception requirements as outlined in the study protocol

• Be willing and able to follow the study procedures and visits as outlined in the protocol

• Additional criteria may apply

Exclusion Criteria:

• Pregnant, planning to become pregnant, or breastfeeding

• A positive urine drug test for drugs of abuse

• Poses a current suicide risk

• Additional criteria may apply