Phase 3
N=66
A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02085135 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Number of Subjects With Adverse Events (AEs) — 27; 28 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
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Adverse Events (AEs) |
27; 28 | — |
Summary
This is a Phase 3 study designed to evaluate the safety and tolerability of two titration schedules for ALKS 5461.
Eligibility Criteria
Inclusion Criteria
- Body mass index of 18-40 kg/m2
- Have a diagnosis of MDD
- Have a current major depressive episode (MDE) lasting 8 weeks to 24 months
- Have been treated with an adequate dose of an approved antidepressant during the current MDE for at least 8 weeks
- Have an inadequate response to current antidepressant treatment
- Agree to use an approved method of birth control for the duration of the study
- Additional criteria may apply
Exclusion Criteria
- Currently pregnant or breastfeeding
- History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV)
- Have experienced hallucinations, delusions, or any psychotic symptoms in the current MDE
- Have used opioid agonists (eg, codeine, oxycodone, tramadol, or morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
- Have received electroconvulsive therapy treatment within the last 5 years
- 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 with 60 days of screening
- Additional criteria may apply
Data sourced from ClinicalTrials.gov (NCT02085135). 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.