Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
347 participants
INTERVENTIONAL
2013-06-30
2015-03-31
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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Low Dose
Olanzapine + low dose samidorphan tablets taken once daily
Samidorphan (Low Dose)
Tablets taken once daily
Olanzapine
Tablets taken once daily
Medium Dose
Olanzapine + medium dose samidorphan tablets taken once daily
Samidorphan (Medium Dose)
Tablets taken once daily
Olanzapine
Tablets taken once daily
High Dose
Olanzapine + high dose samidorphan tablets taken once daily
Samidorphan (High Dose)
Tablets taken once daily
Olanzapine
Tablets taken once daily
Placebo
Olanzapine + placebo tablets taken once daily
Placebo
Tablets taken once daily
Olanzapine
Tablets taken once daily
Interventions
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Samidorphan (Low Dose)
Tablets taken once daily
Samidorphan (Medium Dose)
Tablets taken once daily
Samidorphan (High Dose)
Tablets taken once daily
Placebo
Tablets taken once daily
Olanzapine
Tablets taken once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) of 17-30 kg/m2, inclusive
* Diagnosis of schizophrenia that is clinically stable
Exclusion Criteria
* Current diagnosis of alcohol or drug use disorder, moderate or severe
* Clinically significant or unstable medical illness, condition, or disorder
* Pregnant or breastfeeding
* Significant changes in diet or exercise regimen or plans to join a weight management program during the study
* Opioid medications taken within 14 days and/or need to take opioid medication during the study period
* History of hypersensitivity to or intolerance of olanzapine
* Use of olanzapine, clozapine, mesoridazine, chlorpromazine, or thioridazine for more than 1 week during the past year
18 Years
50 Years
ALL
No
Sponsors
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Alkermes, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bernard L. Silverman, MD
Role: STUDY_DIRECTOR
Alkermes, Inc.
Locations
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Alkermes Investigational Site
Little Rock, Arkansas, United States
Alkermes Investigational Site
Anaheim, California, United States
Alkermes Investigational Site
Costa Mesa, California, United States
Alkermes Investigational Site
Culver City, California, United States
Alkermes Investigational Site
Escondido, California, United States
Alkermes Investigational Site
Garden Grove, 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
Pico Rivera, California, United States
Alkermes Investigational Site
San Diego, California, United States
Alkermes Investigational Site
Torrance, California, United States
Alkermes Investigational Site
New Britain, Connecticut, United States
Alkermes Investigational Site
Washington D.C., District of Columbia, United States
Alkermes Investigational Site
Bradenton, Florida, United States
Alkermes Investigational Site
Fort Lauderdale, Florida, United States
Alkermes Investigational Site
Gainesville, Florida, United States
Alkermes Investigational Site
Kissimmee, Florida, United States
Alkermes Investigational Site
Leesburg, Florida, United States
Alkermes Investigational Site
Oakland Park, Florida, United States
Alkermes Investigational Site
Orlando, Florida, United States
Alkermes Investigational Site
Atlanta, Georgia, United States
Alkermes Investigational Site
Decatur, Georgia, United States
Alkermes Investigational Site
Chicago, Illinois, United States
Alkermes Investigational Site
Lake Charles, Louisiana, United States
Alkermes Investigational Site
Shreveport, Louisiana, United States
Alkermes Investigational Site
Rockville, Maryland, United States
Alkermes Investigational Site
Flowood, Mississippi, United States
Alkermes Investigational Site
Creve Coeur, Missouri, United States
Alkermes Investigational Site
St Louis, Missouri, United States
Alkermes Investigational Site
Marlton, New Jersey, United States
Alkermes Investigational Site
Neptune City, New Jersey, United States
Alkermes Investigational Site
Canton, Ohio, United States
Alkermes Investigational Site
Mason, Ohio, United States
Alkermes Investigational Site
Oklahoma City, Oklahoma, 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
Memphis, Tennessee, United States
Alkermes Investigational Site
Austin, Texas, United States
Alkermes Investigational Site
Austin, Texas, United States
Alkermes Investigational Site
Dallas, Texas, United States
Alkermes Investigational Site
Dallas, Texas, United States
Alkermes Investigational Site
DeSoto, Texas, United States
Alkermes Investigational Site
Houston, Texas, United States
Alkermes Investigational Site
Houston, Texas, United States
Alkermes Investigational Site
Salt Lake City, Utah, United States
Alkermes Investigational Site
Bellevue, Washington, United States
Alkermes Investigational Site
Richland, 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
Pazardzhik, , Bulgaria
Alkermes Investigational Site
Sofia, , Bulgaria
Alkermes Investigational Site
Tserova Koria, , Bulgaria
Alkermes Investigational Site
Varna, , Bulgaria
Alkermes Investigational Site
Vratsa, , Bulgaria
Alkermes Investigational Site
Brno-mesto, , Czechia
Alkermes Investigational Site
Prague, , Czechia
Countries
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References
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Martin WF, Correll CU, Weiden PJ, Jiang Y, Pathak S, DiPetrillo L, Silverman BL, Ehrich EW. Mitigation of Olanzapine-Induced Weight Gain With Samidorphan, an Opioid Antagonist: A Randomized Double-Blind Phase 2 Study in Patients With Schizophrenia. Am J Psychiatry. 2019 Jun 1;176(6):457-467. doi: 10.1176/appi.ajp.2018.18030280. Epub 2019 Mar 8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ALK3831-302
Identifier Type: -
Identifier Source: org_study_id
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