A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy and safety of ALKS 5461.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Buprenorphine; Naltrexone

Criteria

Inclusion Criteria:

• Have a Body Mass Index (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 a Major Depressive Disorder (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 Criteria:

• 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 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