Phase 3
N=1,485
A Long-Term Safety Study of ALKS 5461
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02141399 ↗Enrolled (actual)
1,485
Serious AEs
3.2%
Results posted
Dec 2018
Primary outcome: Primary: Incidence of Adverse Events (AEs) — 1124 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ALKS 5461 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alkermes, Inc.
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events (AEs) |
1124 | — |
Summary
This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02141399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.