A Study of ALKS 3831 in Adults With Schizophrenia
A Phase 2, Randomized, Multicenter, Safety, Tolerability, and Dose-Ranging Study of Samidorphan, a Component of ALKS 3831, in Adults With Schizophrenia Treated With Olanzapine
1 other identifier
interventional
347
3 countries
61
Brief Summary
This is a Phase 2, randomized, placebo-controlled multicenter study, which will be conducted in 2 parts. The study duration for each subject will be approximately 33 weeks and will include 25 study visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 schizophrenia
Started Jun 2013
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 5, 2013
CompletedFirst Posted
Study publicly available on registry
July 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
September 8, 2021
CompletedOctober 6, 2021
September 1, 2021
1.5 years
July 5, 2013
June 22, 2021
September 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score
Change from baseline (Day 8) to Day 92 (end of study Part A). The PANSS is a 30-item scale measuring severity of schizophrenia symptoms. Symptom severity for each item is rated on a 7-point scale (1 = absent; 7 = extreme), and the total score is added together, with a minimum score of 30 and a maximum score of 210. A higher score indicates more severe symptoms, while a lower score indicates less severe symptoms.
Baseline (Day 8) to Day 92 (end of study Part A)
Secondary Outcomes (4)
Percent Change in Body Weight (Kilogram) From Baseline to Day 92
Baseline (Day 8) to Day 92 (end of study Part A)
Absolute Change in Body Weight (kg) From Baseline to Day 92
Baseline (Day 8) to Day 92 (end of study Part A)
Percentage of Subjects Exhibiting Significant Weight Gain at Day 92
Baseline (Day 8) to Day 92 (end of study Part A)
Change in Clinical Global Impressions - Severity (CGI-S) From Baseline to Day 92
Baseline (Day 8) to Day 92 (end of study Part A)
Study Arms (4)
Low Dose
EXPERIMENTALOlanzapine + low dose samidorphan tablets taken once daily
Medium Dose
EXPERIMENTALOlanzapine + medium dose samidorphan tablets taken once daily
High Dose
EXPERIMENTALOlanzapine + high dose samidorphan tablets taken once daily
Placebo
PLACEBO COMPARATOROlanzapine + placebo tablets taken once daily
Interventions
Tablets taken once daily
Tablets taken once daily
Tablets taken once daily
Eligibility Criteria
You may qualify if:
- Age 18 to 50 years, inclusive
- Body mass index (BMI) of 17-30 kg/m2, inclusive
- Diagnosis of schizophrenia that is clinically stable
You may not qualify if:
- Initiated 1st antipsychotic treatment within the past 12 months and/or has had symptoms lasting \<2 years
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alkermes, Inc.lead
Study Sites (61)
Alkermes Investigational Site
Little Rock, Arkansas, 72211, United States
Alkermes Investigational Site
Anaheim, California, 92805, United States
Alkermes Investigational Site
Costa Mesa, California, 92626, United States
Alkermes Investigational Site
Culver City, California, 90230, United States
Alkermes Investigational Site
Escondido, California, 92025, United States
Alkermes Investigational Site
Garden Grove, California, 92845, United States
Alkermes Investigational Site
National City, California, 91950, United States
Alkermes Investigational Site
Oakland, California, 94612, United States
Alkermes Investigational Site
Oceanside, California, 92056, United States
Alkermes Investigational Site
Orange, California, 92868, United States
Alkermes Investigational Site
Pico Rivera, California, 90660, United States
Alkermes Investigational Site
San Diego, California, 92103, United States
Alkermes Investigational Site
Torrance, California, 90502, United States
Alkermes Investigational Site
New Britain, Connecticut, 06052, United States
Alkermes Investigational Site
Washington D.C., District of Columbia, 20016, United States
Alkermes Investigational Site
Bradenton, Florida, 34208, United States
Alkermes Investigational Site
Fort Lauderdale, Florida, 33308, United States
Alkermes Investigational Site
Gainesville, Florida, 32607, United States
Alkermes Investigational Site
Kissimmee, Florida, 34741, United States
Alkermes Investigational Site
Leesburg, Florida, 34748, United States
Alkermes Investigational Site
Oakland Park, Florida, 33334, United States
Alkermes Investigational Site
Orlando, Florida, 32810, United States
Alkermes Investigational Site
Atlanta, Georgia, 30308, United States
Alkermes Investigational Site
Decatur, Georgia, 30030, United States
Alkermes Investigational Site
Chicago, Illinois, 60640, United States
Alkermes Investigational Site
Lake Charles, Louisiana, 70629, United States
Alkermes Investigational Site
Shreveport, Louisiana, 71101, United States
Alkermes Investigational Site
Rockville, Maryland, 20850, United States
Alkermes Investigational Site
Flowood, Mississippi, 39232, United States
Alkermes Investigational Site
Creve Coeur, Missouri, 63141, United States
Alkermes Investigational Site
St Louis, Missouri, 63118, United States
Alkermes Investigational Site
Marlton, New Jersey, 08053, United States
Alkermes Investigational Site
Neptune City, New Jersey, 07754, United States
Alkermes Investigational Site
Canton, Ohio, 44718, United States
Alkermes Investigational Site
Mason, Ohio, 45040, United States
Alkermes Investigational Site
Oklahoma City, Oklahoma, 73103, United States
Alkermes Investigational Site
Oklahoma City, Oklahoma, 73116, United States
Alkermes Investigational Site
Philadelphia, Pennsylvania, 19139, United States
Alkermes Investigational Site
Charleston, South Carolina, 29407, United States
Alkermes Investigational Site
Memphis, Tennessee, 38119, United States
Alkermes Investigational Site
Austin, Texas, 78731, United States
Alkermes Investigational Site
Austin, Texas, 78754, United States
Alkermes Investigational Site
Dallas, Texas, 75231, United States
Alkermes Investigational Site
Dallas, Texas, 75243, United States
Alkermes Investigational Site
DeSoto, Texas, 75115, United States
Alkermes Investigational Site
Houston, Texas, 77007, United States
Alkermes Investigational Site
Houston, Texas, 77008, United States
Alkermes Investigational Site
Salt Lake City, Utah, 84106, United States
Alkermes Investigational Site
Bellevue, Washington, 98007, United States
Alkermes Investigational Site
Richland, Washington, 99362, United States
Alkermes Investigational Site
Burgas, 8000, Bulgaria
Alkermes Investigational Site
Kazanlak, 6100, Bulgaria
Alkermes Investigational Site
Lovech, 5500, Bulgaria
Alkermes Investigational Site
Novi Iskar, 1280, Bulgaria
Alkermes Investigational Site
Pazardzhik, 4400, Bulgaria
Alkermes Investigational Site
Sofia, 1606, Bulgaria
Alkermes Investigational Site
Tserova Koria, 8260, Bulgaria
Alkermes Investigational Site
Varna, 9020, Bulgaria
Alkermes Investigational Site
Vratsa, 3000, Bulgaria
Alkermes Investigational Site
Brno-mesto, Czechia
Alkermes Investigational Site
Prague, Czechia
Related Publications (1)
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.
PMID: 30845818RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Corporate and R&D Communications
- Organization
- Alkermes
Study Officials
- STUDY DIRECTOR
Bernard L. Silverman, MD
Alkermes, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2013
First Posted
July 19, 2013
Study Start
June 1, 2013
Primary Completion
December 1, 2014
Study Completion
March 1, 2015
Last Updated
October 6, 2021
Results First Posted
September 8, 2021
Record last verified: 2021-09