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