A Long-Term Safety Study of ALKS 5461

Alkermes

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: ALKS 5461

Study type: Interventional

Funder types: Industry

Identifiers

NCT02141399

ALK5461-208

Details and patient eligibility

About

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

Enrollment: 1,485 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,485 participants in 1 patient group

ALKS 5461

Experimental group

Treatment:

Drug: ALKS 5461