A Long-Term Safety Study of ALKS 5461
- Registration Number
- NCT02141399
- Lead Sponsor
- Alkermes, Inc.
- Brief Summary
This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1485
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ALKS 5461 ALKS 5461 -
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) Up to 56 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Alkermes Investigational Site
🇵🇷San Juan, Puerto Rico