Status:
COMPLETED
A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)
Lead Sponsor:
Alkermes, Inc.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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.
Detailed 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT01500200
Start Date
December 1 2011
End Date
March 1 2013
Last Update
May 21 2019
Active Locations (27)
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1
Alkermes Investigational Site
Tucson, Arizona, United States, 85712
2
Alkermes Investigational Site
Oceanside, California, United States, 92056
3
Alkermes Investigational Site
Santa Ana, California, United States, 92701
4
Alkermes Investigational Site
Torrance, California, United States, 90502