A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 3 study designed to evaluate the safety and tolerability of two titration schedules for ALKS 5461.

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

Details

• Lead Sponsor: Alkermes, Inc.

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