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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which ALKS 5461 modulates neurotransmitter systems in Major Depressive Disorder?
How does the long-term safety profile of ALKS 5461 compare to standard-of-care antidepressants in treatment-resistant depression?
What biomarkers are associated with improved outcomes in patients receiving ALKS 5461 adjunctive therapy for MDD?
What adverse events were observed in the 52-week Phase 3 FORWARD-2 study of ALKS 5461 and how were they managed?
Are there any combination therapies or competitor drugs showing similar efficacy to ALKS 5461 in adjunctive MDD treatment?
Trial Locations
- Locations (1)
Alkermes Investigational Site
🇵🇷San Juan, Puerto Rico
Alkermes Investigational Site🇵🇷San Juan, Puerto Rico