A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)

Exclusion Criteria

• •Has any finding that would compromise the safety of the subject or affect their ability to adhere to the protocol visit schedule or fulfill visit requirements
• •Has any other significant medical condition (eg, neurological, psychiatric, or metabolic) or clinical symptom that could unduly risk the subject or affect the interpretation of study data
• •Has any current primary diagnosis other than MDD, where primary diagnosis is defined as the primary source of current distress and functional impairment
• •Has experienced hallucinations, delusions, or any psychotic symptoms in the current MDE
• •Has been hospitalized for MDD within 3 months before screening
• •Has used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days prior to screening
• •Has received electroconvulsive therapy treatment within the last 2 years or within the current MDE or failed a course of electroconvulsive treatment at any time
• •Has a significant risk for suicide
• •Has a positive breath alcohol test at screening
• •Has a positive test for drugs of abuse at screening or visit 2
• •Is pregnant, planning to become pregnant, or is breastfeeding during the study
• •Additional criteria may apply