NCT05303064 · Alkermes, Inc.
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
What this study is about
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
View original scientific description
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
Interventions
DRUG
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.
DRUG
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
Primary outcome measures
Change from baseline in body mass index (BMI) Zscore at week 12
Time frame: 12 weeks
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Dothan, Alabama
- Little Rock, Arkansas
- Encino, California
- Stanford, California
- Upland, California
- Colorado Springs, Colorado
- Denver, Colorado
- Hartford, Connecticut
- Washington D.C., District of Columbia
- Miami, Florida
- Miami Lakes, Florida
- Decatur, Georgia
And 14 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 14, 2026 · Source of record for eligibility and locations