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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

RecruitingPhase 3

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)

Who can join

Ages 10 to 17 · All sexes

Full eligibility criteria
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

About the study

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

What is being tested

Sponsor: Alkermes, Inc. · Participants: 220 · Started: Jun 30, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05303064

Locations in the U.S.

AlabamaAlkermes Investigator Site, Dothan
ArkansasAlkermes Investigator Site, Little Rock
CaliforniaAlkermes Investigator Site, Stanford
District of ColumbiaAlkermes Investigator Site, Washington D.C.
FloridaAlkermes Investigator Site, Miami Lakes
GeorgiaAlkermes Investigator Site, Decatur
IllinoisAlkermes Investigator Site, Chicago
IndianaAlkermes Investigator Site, Indianapolis
MissouriAlkermes Investigator Site, Saint Charles
NebraskaAlkermes Investigator Site, Lincoln
New YorkAlkermes Investigator Site, New York
OhioAlkermes Investigator Site, Cincinnati
Alkermes Investigator Site, West Chester
VirginiaAlkermes Investigational Site, Richmond
WashingtonAlkermes Investigator Site, Everett

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.