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

Description

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

Conditions

Schizophrenia, Bipolar I Disorder

Study Overview

Study Details

Study overview

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

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)

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

Condition
Schizophrenia
Intervention / Treatment

-

Contacts and Locations

Dothan

Alkermes Investigator Site, Dothan, Alabama, United States, 36303

Encino

Alkermes Investigator Site, Encino, California, United States, 91316

Stanford

Alkermes Investigator Site, Stanford, California, United States, 94305

Upland

Alkermes Investigator Site, Upland, California, United States, 91786

Colorado Springs

Alkermes Investigator Site, Colorado Springs, Colorado, United States, 80910

Hartford

Alkermes Investigator Site, Hartford, Connecticut, United States, 06106

Washington

Alkermes Investigator Site, Washington, District of Columbia, United States, 20010

Miami Lakes

Alkermes Investigator Site, Miami Lakes, Florida, United States, 33016

Miami

Alkermes Investigator Site, Miami, Florida, United States, 33155

Decatur

Alkermes Investigator Site, Decatur, Georgia, United States, 30030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

10 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alkermes, Inc.,

David McDonnell, MD, STUDY_DIRECTOR, Alkermes, Inc.

Study Record Dates

2026-09