A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.

Criteria

Inclusion Criteria:

• Diagnosed with a major depressive episode (MDE)

• Body mass index less than or equal to 40 kg/m2

• Have been treated with an adequate dose of SSRI/SNRI during the current MDE for at least 8 weeks, with the same, adequate dose over the last 4 weeks that is expected to remain stable throughout the study

• History of inadequate response during the entire current MDE to 1 or 2 adequate antidepressant treatments, including current treatment

• Be otherwise physically healthy

Exclusion Criteria:

• Have an axis I diagnosis of delirium, dementia, amnestic or other cognitive disorder, schizophrenia or other psychotic disorder, bipolar I or II disorder, eating disorder, obsessive-compulsive disorder, panic disorder, acute stress disorder, or posttraumatic stress disorder

• Have a clinically significant current axis II diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder

• Are experiencing hallucinations, delusions, or any psychotic symptomatology in the current MDE

• Receive new onset psychotherapy within 6 weeks of screening

• Use of opioid agonists (eg, codeine, oxycodone, morphine) within 14 days before screening

• Have received electroconvulsive therapy during the current MDE

• Have attempted suicide within the past 2 years

• Have a thyroid pathology

• Have a history of a seizure disorder or of neuroleptic malignant syndrome/serotonin syndrome

• Have a positive test for human immunodeficiency virus (HIV)

Additional inclusion/exclusion criteria may apply