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

• Status: Completed
• Trial end date: 2020-03-05
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in adults who have treatment refractory MDD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Buprenorphine; Naltrexone

Criteria

Inclusion Criteria:

• Have a Major Depressive Disorder (MDD) primary diagnosis

• Have a body mass index (BMI) of 18.0 to
• Be willing and able to follow the study procedures and visits as outlined in the protocol (including agreeing not to enroll in any other clinical trials)

• Have inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)

• Additional criteria may apply

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