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

A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Tolerability of Two Titration Schedules for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults With an Inadequate Response to Antidepressant Therapy (the FORWARD-1 Study)

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

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