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Study for Weight Gain in Pediatric Schizophrenia or Bipolar I Disorder

This study is looking at how two different treatments affect weight gain in young people with schizophrenia or bipolar I disorder. Researchers are comparing OLZ/SAM (a combination of olanzapine and samidorphan) with olanzapine alone. The main goal is to see how much a participant's Body Mass Index (BMI) Z-score changes after 12 weeks of treatment. You may be able to join if you are 10 to 17 years old with bipolar I disorder, or 13 to 17 years old with schizophrenia, and can be treated as an outpatient. The current status of this study is unclear, and it plans to enroll about 220 participants.

Study design
This is an interventional study comparing two drug treatments. It plans to enroll 220 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main measurement for this study is taken at 12 weeks after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05303064

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

Recruiting
PHASE3Ages 10–17InterventionalTreatment
Alkermes, Inc.
~220 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:OLZ/SAMOlanzapine

At a glance

Recruiting sites
35 of 47 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in body mass index (BMI) Zscore at week 12
Measured over 12 weeks

Conditions

Schizophrenia
Bipolar I Disorder

Explore related trials

Bipolar I disorderSchizophrenia

Where it's being run

47 sites across 26 states
Colombia5
Mexico5
Brazil4
California3
Argentina3
Colorado2
Florida2
Nebraska2

Study leadership

  • David McDonnell, MD · STUDY_DIRECTOR · Alkermes, Inc.

Who to contact

Global Clinical Services
[email protected]
888-235-8008 (US Only)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Subjects aged 13 to 17 years with schizophrenia or aged 10 to 17 years with bipolar I disorder, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) 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

Subject presents with a major depressive episode(bipolar I disorder) or other neuropsychiatric diagnosis (according to DSM-5 criteria) including schizoaffective disorder, current major depressive disorder that is untreated and/or unstable, or any other psychiatric condition that could interfere with participation in the study
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

What this trial measures

  • Change from baseline in body mass index (BMI) Zscore at week 1212 weeks

    To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine