A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)
A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)
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.
The study will measure efficacy using the HAM-D-17, the MADRS, and the CGI-S as well as using
 other scales and assessments.
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