Status:
COMPLETED
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study
Lead Sponsor:
Alkermes, Inc.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy and safety of ALKS 5461.
Eligibility Criteria
Inclusion
- Have a BMI of 18.0 to 40.0 kg/m2, inclusive
- Agree to use an acceptable method of contraception for the duration of the study
- Have an MDD primary diagnosis
- Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
- Additional criteria may apply
Exclusion
- 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 one course of electroconvulsive treatment during their lifetime
- Have attempted suicide within the past 2 years
- Have a positive test for drugs of abuse
- Are pregnant, planning to become pregnant, or breastfeeding
- 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 60 days
- Additional criteria may apply
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT02218008
Start Date
July 1 2014
End Date
October 1 2016
Last Update
August 14 2019
Active Locations (44)
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1
Alkermes Investigational Site
Birmingham, Alabama, United States, 35294
2
Alkermes Investigational Site
Colton, California, United States, 92324
3
Alkermes Investigational Site
Garden Grove, California, United States, 92845
4
Alkermes Investigational Site
Los Angeles, California, United States, 90024