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

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