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

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