Ireland
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Recruiting Phase 3

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

NCT05303064 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 3
Started
2022-06-30
Last updated
2026-08-14

Condition(s) studied

SchizophreniaBipolar I Disorder

Investigational drug(s) / intervention(s)

OLZ/SAM →Olanzapine →

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

Study summary

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

Eligibility

Sex
ALL
Min age
10 Years
Max age
17 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change from baseline in body mass index (BMI) Zscore at week 12 — 12 weeks
    To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine

Trial sites (47)

FacilityCityRegionStatus
Alkermes Investigator Site Dothan Alabama Recruiting
Alkermes Investigator Site Little Rock Arkansas Recruiting
Alkermes Investigator Site Encino California Withdrawn
Alkermes Investigator Site Stanford California Recruiting
Alkermes Investigator Site Upland California Withdrawn
Alkermes Investigator Site Colorado Springs Colorado Withdrawn
Alkermes Investigator Site Denver Colorado Active Not Recruiting
Alkermes Investigator Site Hartford Connecticut Withdrawn
Alkermes Investigator Site Washington D.C. District of Columbia Recruiting
Alkermes Investigator Site Miami Florida Withdrawn
Alkermes Investigator Site Miami Lakes Florida Recruiting
Alkermes Investigator Site Decatur Georgia Recruiting
Alkermes Investigator Site Chicago Illinois Recruiting
Alkermes Investigator Site Indianapolis Indiana Recruiting
Alkermes Investigator Site Saint Charles Missouri Recruiting
Alkermes Investigator Site Lincoln Nebraska Recruiting
Alkermes Investigator Site Omaha Nebraska Withdrawn
Alkermes Investigator Site Paramus New Jersey Withdrawn
Alkermes Investigator Site New York New York Recruiting
Alkermes Investigational Site Kinston North Carolina Withdrawn
Alkermes Investigator Site Cincinnati Ohio Recruiting
Alkermes Investigator Site West Chester Ohio Recruiting
Alkermes Investigator Site DeSoto Texas Terminated
Alkermes Investigator Site Fort Worth Texas Withdrawn
Alkermes Investigational Site Richmond Virginia Recruiting
Alkermes Investigator Site Everett Washington Recruiting
Alkermes Investigator Site La Plata Buenos Aires Recruiting
Alkermes Investigator Site La Plata Buenos Aires Recruiting
Alkermes Investigator Site Buenos Aires Argentina Recruiting
Alkermes Investigator Site Córdoba Argentina Recruiting
Alkermes Investigator Site Mendoza Argentina Recruiting
Alkermes Investigator Site Fortaleza Ceará Recruiting
Alkermes Investigator Site Curitiba Paraná Recruiting
Alkermes Investigator Site Goiânia Brazil Recruiting
Alkermes Investigator Site Rio de Janeiro Brazil Recruiting
Alkermes Investigator Site São Paulo Brazil Recruiting
Alkermes Investigator Site São Paulo Brazil Recruiting
Alkermes Investigator Site Barranquilla Colombia Recruiting
Alkermes Investigator Site Bello Colombia Recruiting
Alkermes Investigator Site Bogotá Colombia Active Not Recruiting

+ 7 more sites — see the full list on the official registry below.

More Alkermes, Inc. trials in Mexico

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05303064 on ClinicalTrials.gov ↗ ← All trials in Mexico