Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
NCT ID: NCT05303064
Last Updated: 2025-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
220 participants
INTERVENTIONAL
2022-06-30
2026-09-30
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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Group 1 OLZ/SAM
Fixed dose combination of olanzapine and samidorphan
OLZ/SAM
OLZ/SAM refers to the fixed dose combination of olanzapine and samidorphan. The starting dose of olanzapine will be 2.5 mg/day or 5 mg/day at the discretion of the Investigator with a maximum daily dose of 20mg/day. The starting dose of samidorphan will be 5 or 10 mg.
Group 2 Olanzapine
Fixed dose of olanzapine
Olanzapine
The starting dose of olanzapine will be 2.5 mg/day or 5 mg/day at the discretion of the Investigator with a maximum daily dose of 20mg/day
Interventions
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OLZ/SAM
OLZ/SAM refers to the fixed dose combination of olanzapine and samidorphan. The starting dose of olanzapine will be 2.5 mg/day or 5 mg/day at the discretion of the Investigator with a maximum daily dose of 20mg/day. The starting dose of samidorphan will be 5 or 10 mg.
Olanzapine
The starting dose of olanzapine will be 2.5 mg/day or 5 mg/day at the discretion of the Investigator with a maximum daily dose of 20mg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is an outpatient or will be able to be treated on an outpatient basis (per Investigator judgement) by study Week 2
* Subject has reliable family/legal guardian support available for outpatient management
* Subject is either currently treated with olanzapine, or if treated with another antipsychotic, the subject has had an inadequate response (eg, unsatisfactory clinical response, AEs, or nonadherence to current medication) based on Investigator judgment
* Subject must not be a danger to self or others (per Investigator judgement)
Exclusion Criteria
* Subject has a history of seizure disorder (exception: history of febrile seizures), severe head trauma with loss of consciousness within the 12 months prior to Screening, or other clinically significant neurological condition within the 12 months prior to Screening
* Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale (C-SSRS)
* Subject has received olanzapine for \>= 14 days during the month prior to screening, or has a history of poor or inadequate response to treatment with olanzapine
* Subject has taken opioid agonists within 14 days prior to Screening, or within 30 days prior to Screening (for long-acting opioid agonists)
* Subject anticipates needing to take opioid medication during the study period (eg, planned surgery, including oral surgery)
* Subject has taken opioid antagonists including naltrexone (any formulation) or naloxone within 60 days prior to Screening
* Subject has used a long-acting injectable antipsychotic medication within 3 injection cycles prior to Screening
* Subject has a BMI percentile \>98th or \<5th
* Subject has a diagnosis of diabetes mellitus or presents with prediabetes lab results at Screening (hemoglobin A1c \[HbA1c\] \>= 6%)
* Subject has started a smoking cessation program within the 6 months prior to Screening or has joined a weight management program or has had significant changes in diet or exercise regimen within 6 weeks prior to Screening
* Subject has participated in a clinical study of an investigational product within the last 30 days prior to Screening
10 Years
17 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 Investigator Site
Dothan, Alabama, United States
Alkermes Investigator Site
Little Rock, Arkansas, United States
Alkermes Investigator Site
Encino, California, United States
Alkermes Investigator Site
Stanford, California, United States
Alkermes Investigator Site
Upland, California, United States
Alkermes Investigator Site
Colorado Springs, Colorado, United States
Alkermes Investigator Site
Denver, Colorado, United States
Alkermes Investigator Site
Hartford, Connecticut, United States
Alkermes Investigator Site
Washington D.C., District of Columbia, United States
Alkermes Investigator Site
Miami, Florida, United States
Alkermes Investigator Site
Miami Lakes, Florida, United States
Alkermes Investigator Site
Decatur, Georgia, United States
Alkermes Investigator Site
Chicago, Illinois, United States
Alkermes Investigator Site
Indianapolis, Indiana, United States
Alkermes Investigator Site
Saint Charles, Missouri, United States
Alkermes Investigator Site
Lincoln, Nebraska, United States
Alkermes Investigator Site
Omaha, Nebraska, United States
Alkermes Investigator Site
Paramus, New Jersey, United States
Alkermes Investigator Site
New York, New York, United States
Alkermes Investigational Site
Kinston, North Carolina, United States
Alkermes Investigator Site
Cincinnati, Ohio, United States
Alkermes Investigator Site
West Chester, Ohio, United States
Alkermes Investigator Site
DeSoto, Texas, United States
Alkermes Investigator Site
Fort Worth, Texas, United States
Alkermes Investigational Site
Richmond, Virginia, United States
Alkermes Investigator Site
Everett, Washington, United States
Alkermes Investigator Site
La Plata, Buenos Aires, Argentina
Alkermes Investigator Site
La Plata, Buenos Aires, Argentina
Alkermes Investigator Site
Buenos Aires, , Argentina
Alkermes Investigator Site
Córdoba, , Argentina
Alkermes Investigator Site
Mendoza, , Argentina
Alkermes Investigator Site
Fortaleza, Ceará, Brazil
Alkermes Investigator Site
Curitiba, Paraná, Brazil
Alkermes Investigator Site
Goiânia, , Brazil
Alkermes Investigator Site
Rio de Janeiro, , Brazil
Alkermes Investigator Site
São Paulo, , Brazil
Alkermes Investigator Site
São Paulo, , Brazil
Alkermes Investigator Site
Barranquilla, , Colombia
Alkermes Investigator Site
Bello, , Colombia
Alkermes Investigator Site
Bogotá, , Colombia
Alkermes Investigator Site
Bogotá, , Colombia
Alkermes Investigator Site
Pereira, , Colombia
Alkermes Investigator Site
Culiacán, , Mexico
Alkermes Investigator Site
Estado de México, , Mexico
Alkermes Investigator Site
León, , Mexico
Alkermes Investigator Site
Monterrey, , Mexico
Alkermes Investigator Site
Monterrey, , Mexico
Countries
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Central Contacts
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Other Identifiers
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ALKS 3831-A312
Identifier Type: -
Identifier Source: org_study_id
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