A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder
NCT ID: NCT02161718
Last Updated: 2021-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
300 participants
INTERVENTIONAL
2014-05-31
2017-02-01
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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Samidorphan + olanzapine (ALKS 3831)
Active study drug
Samidorphan + olanzapine (ALKS 3831)
Oral tablet, taken once daily
Placebo + olanzapine
Placebo + olanzapine
Oral tablet, taken once daily
Interventions
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Samidorphan + olanzapine (ALKS 3831)
Oral tablet, taken once daily
Placebo + olanzapine
Oral tablet, taken once daily
Eligibility Criteria
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Inclusion Criteria
* Has a diagnosis of schizophrenia
* Has a diagnosis of alcohol use disorder (AUD)
* Has experienced an acute exacerbation of schizophrenia within the past 6 months
* Additional criteria may apply
Exclusion Criteria
* Had first lifetime psychotic episode less than 1 year before screening or has experienced only a single lifetime psychotic episode
* Has a known or suspected intolerance, allergy, or hypersensitivity to olanzapine
* Has current or pending legal charges with the potential for incarceration
* Has a positive drug screen for opiates
* Additional criteria may apply
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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David McDonnell, MD
Role: STUDY_DIRECTOR
Alkermes, Inc.
Locations
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Alkermes Investigational Site
Little Rock, Arkansas, United States
Alkermes Investigational Site
Springdale, Arkansas, United States
Alkermes Investigational Site
Anaheim, California, United States
Alkermes Investigational Site
Culver City, California, United States
Alkermes Investigational Site
Garden Grove, California, United States
Alkermes Investigational Site
Irvine, California, United States
Alkermes Investigational Site
La Jolla, California, United States
Alkermes Investigational Site
Long Beach, California, United States
Alkermes Investigational Site
National City, California, United States
Alkermes Investigational Site
Oakland, California, United States
Alkermes Investigational Site
Oceanside, California, United States
Alkermes Investigational Site
Orange, California, United States
Alkermes Investigational Site
San Diego, California, United States
Alkermes Investigational Site
San Francisco, California, United States
Alkermes Investigational Site
Torrance, California, United States
Alkermes Investigational Site
Washington D.C., District of Columbia, United States
Alkermes Investigational Site
Fort Lauderdale, Florida, United States
Alkermes Investigational Site
Leesburg, Florida, United States
Alkermes Investigational Site
Maitland, Florida, United States
Alkermes Investigational Site
Miami, Florida, United States
Alkermes Investigational Site
Miami, Florida, United States
Alkermes Investigational Site
North Miami, Florida, United States
Alkermes Investigational Site
Oakland Park, Florida, United States
Alkermes Investigational Site
Orlando, Florida, United States
Alkermes Investigational Site
Tampa, Florida, United States
Alkermes Investigational Site
Atlanta, Georgia, United States
Alkermes Investigational Site
Augusta, Georgia, United States
Alkermes Investigational Site
Decatur, Georgia, United States
Alkermes Investigational Site
Chicago, Illinois, United States
Alkermes Investigational Site
Hoffman Estates, Illinois, United States
Alkermes Investigational Site
Oak Brook, Illinois, United States
Alkermes Investigational Site
Shreveport, Louisiana, United States
Alkermes Investigational Site
Worcester, Massachusetts, United States
Alkermes Investigational Site
Flowood, Mississippi, United States
Alkermes Investigational Site
Creve Coeur, Missouri, United States
Alkermes Investigational Site
Kansas City, Missouri, United States
Alkermes Investigational Site
St Louis, Missouri, United States
Alkermes Investigational Site
Las Vegas, Nevada, United States
Alkermes Investigational Site
Claremont, New Hampshire, United States
Alkermes Investigational Site
Nashua, New Hampshire, United States
Alkermes Investigational Site
Neptune City, New Jersey, United States
Alkermes Investigational Site
Cedarhurst, New York, United States
Alkermes Investigational Site
Jamaica, New York, United States
Alkermes Investigational Site
New York, New York, United States
Alkermes Investigational Site
New York, New York, United States
Alkermes Investigational Site
New York, New York, United States
Alkermes Investigational Site
Rochester, New York, United States
Alkermes Investigational Site
Staten Island, New York, United States
Alkermes Investigational Site
Dayton, Ohio, United States
Alkermes Investigational Site
Oklahoma City, Oklahoma, United States
Alkermes Investigational Site
Scranton, Pennsylvania, United States
Alkermes Investigational Site
Charleston, South Carolina, United States
Alkermes Investigational Site
Charleston, South Carolina, 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
DeSoto, Texas, United States
Alkermes Investigational Site
Bellevue, Washington, United States
Alkermes Investigational Site
Burgas, , Bulgaria
Alkermes Investigational Site
Kazanlak, , Bulgaria
Alkermes Investigational Site
Lovech, , Bulgaria
Alkermes Investigational Site
Novi Iskar, , Bulgaria
Alkermes Investigational Site
Sofia, , Bulgaria
Alkermes Investigational Site
Tserova Koria, , Bulgaria
Alkermes Investigational Site
Varna, , Bulgaria
Alkermes Investigational Site
Varna, , Bulgaria
Alkermes Investigational Site
Vratsa, , Bulgaria
Alkermes Investigational Site
Bełchatów, , Poland
Alkermes Investigational Site
Bialystok, , Poland
Alkermes Investigational Site
Gdansk, , Poland
Alkermes Investigational Site
Lublin, , Poland
Countries
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References
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Brunette MF, Correll CU, O'Malley SS, McDonnell D, DiPetrillo L, Jiang Y, Simmons A, Silverman BL, Citrome L, Green AI. Olanzapine Plus Samidorphan (ALKS 3831) in Schizophrenia and Comorbid Alcohol Use Disorder: A Phase 2, Randomized Clinical Trial. J Clin Psychiatry. 2020 Mar 10;81(2):19m12786. doi: 10.4088/JCP.19m12786.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ALK3831-401
Identifier Type: -
Identifier Source: org_study_id
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