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

Alkermes

Status and phase

Completed

Phase 2

Conditions

Major Depressive Disorder

Treatments

Drug: ALKS 5461

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01500200

ALK5461-202

Details and patient eligibility

About

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.

Full description

The study will measure efficacy using the HAM-D-17, the MADRS, and the CGI-S as well as using other scales and assessments.

Enrollment

142 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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