A Long-Term Safety Study of ALKS 5461

• Status: Completed
• Trial end date: 2017-11-20
• Target enrollment: 0
• Participant gender: All

Summary

This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.

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

Details

• Lead Sponsor: Alkermes, Inc.

Criteria

Inclusion Criteria:

• Agree to use an approved method of contraception for the duration of the study

• Have the potential to safely benefit from the administration of ALKS 5461

• Have a diagnosis of major depressive disorder (MDD)

• Additional criteria may apply

Exclusion Criteria:

• Have a positive test for drugs of abuse

• Currently pregnant or breastfeeding

• Have a current primary Axis-I disorder other than MDD

• Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days

• Have received electroconvulsive therapy treatment within the last 2 years, or received more than 1 course of electroconvulsive treatment during their lifetime

• Have attempted suicide within the past 2 years

• Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)

• Have had a significant blood loss or blood donation within the past 60 days

• Additional criteria may apply