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

RECRUITINGPHASE3

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

A Phase 3, Randomized, Double-Blind, 52-Week Study of OLZ/SAM vs Olanzapine to Evaluate Weight Gain as Assessed by Change in BMI Z-Score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder (ENLIGHTEN-Youth)

NCT05303064•Alkermes, Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

10 - 17 years

Sex

ALL

Healthy Volunteers

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%)
+2 more criteria

Locations (47)

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

Key Dates

Start Date

June 30, 2022

Primary Completion Date

September 1, 2026

Completion Date

September 1, 2026

Last Updated

February 18, 2026

Enrollment

220

ESTIMATED participants

Conditions

SchizophreniaBipolar I Disorder

Interventions

OLZ/SAM

DRUG

Olanzapine

DRUG

Contacts

Global Clinical Services

CONTACT

888-235-8008 (US Only)clinicaltrials@alkermes.com

Global Clinical Services

CONTACT

1-571-599-2702 (Global)clinicaltrials@alkermes.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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