A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)
NCT ID: NCT01500200
Last Updated: 2019-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
142 participants
INTERVENTIONAL
2011-12-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ALKS 5461
ALKS 5461
Two active tablets, given daily
Placebo
Placebo
Two placebo tablets, given daily
Interventions
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ALKS 5461
Two active tablets, given daily
Placebo
Two placebo tablets, given daily
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
65 Years
ALL
No
Sponsors
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Alkermes, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Richard Leigh-Pemberton, MD
Role: STUDY_DIRECTOR
Alkermes, Inc.
Locations
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Alkermes Investigational Site
Tucson, Arizona, United States
Alkermes Investigational Site
Oceanside, California, United States
Alkermes Investigational Site
Santa Ana, California, United States
Alkermes Investigational Site
Torrance, California, United States
Alkermes Investigational Site
Fort Myers, Florida, United States
Alkermes Investigational Site
Lauderhill, Florida, United States
Alkermes Investigational Site
Leesburg, Florida, United States
Alkermes Investigational Site
North Miami, Florida, United States
Alkermes Investigational Site
St. Petersburg, Florida, United States
Alkermes Investigational Site
Atlanta, Georgia, United States
Alkermes Investigational Site
Hoffman Estates, Illinois, United States
Alkermes Investigational Site
Baltimore, Maryland, United States
Alkermes Investigational Site
Boston, Massachusetts, United States
Alkermes Investigational Site
Haverhill, Massachusetts, United States
Alkermes Investigational Site
Berlin, New Jersey, United States
Alkermes Investigational Site
Brooklyn, New York, United States
Alkermes Investigational Site
New York, New York, United States
Alkermes Investigational Site
Canton, Ohio, United States
Alkermes Investigational Site
Dayton, Ohio, United States
Alkermes Investigational Site
Oklahoma City, Oklahoma, United States
Alkermes Investigational Site
Philadelphia, Pennsylvania, United States
Alkermes Investigational Site
Charleston, South Carolina, United States
Alkermes Investigational Site
Austin, Texas, United States
Alkermes Investigational Site
Dallas, Texas, United States
Alkermes Investigational Site
Houston, Texas, United States
Alkermes Investigational Site
San Antonio, Texas, United States
Alkermes Investigational Site
Bellevue, Washington, United States
Countries
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References
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Fava M, Memisoglu A, Thase ME, Bodkin JA, Trivedi MH, de Somer M, Du Y, Leigh-Pemberton R, DiPetrillo L, Silverman B, Ehrich E. Opioid Modulation With Buprenorphine/Samidorphan as Adjunctive Treatment for Inadequate Response to Antidepressants: A Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2016 May 1;173(5):499-508. doi: 10.1176/appi.ajp.2015.15070921. Epub 2016 Feb 12.
Other Identifiers
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ALK5461-202
Identifier Type: -
Identifier Source: org_study_id
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