RecruitingPhase 3

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares OLZ/SAM with olanzapine to see how they affect weight gain. It measures changes in BMI Z-score, which compares body size with others of the same age and sex. It is for children ages 13–17 with schizophrenia or ages 10–17 with bipolar I disorder.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a diagnosis of schizophrenia at age 13–17, or bipolar I disorder at age 10–17, under standard diagnosis rules.
  • Can receive care without staying in a hospital now or by study week 2, as judged by the study doctor.
  • Have reliable support from family or a legal guardian for care outside the hospital.
  • Currently take olanzapine, or take another antipsychotic medicine that is not working well enough, causes side effects, or is not taken as directed, as judged by the study doctor.
  • Are not a danger to yourself or others, as judged by the study doctor.

Who can't join

  • Have bipolar I disorder with a major episode of depression; schizoaffective disorder; current major depression that is untreated or unstable; or another mental health condition that could affect study participation. A current risk of suicide also rules out joining.
  • Have a history of seizures, except seizures caused by fever. Also excluded: a serious head injury with loss of consciousness or another major brain or nerve condition in the past 12 months.
  • Took olanzapine for 14 or more days in the month before screening, or it did not work well in the past. Also excluded: a long-acting antipsychotic shot within the last 3 scheduled shot cycles.
  • Took opioid medicines within 14 days before screening, or long-acting opioids within 30 days; expect to need opioids during the study; or took opioid-blocking medicines, such as naltrexone or naloxone, within 60 days.
  • Have a BMI below the 5th percentile or above the 98th percentile—a body-size measure compared with others of the same age and sex.
  • Have diabetes, or screening blood tests show prediabetes with an HbA1c result of 6% or higher. HbA1c measures average blood sugar.
  • Started a stop-smoking program within 6 months before screening, or joined a weight-control program or made major diet or exercise changes within 6 weeks.
  • Took part in a study of an experimental treatment or product within 30 days before screening.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (26)

AL

AR

CA

CO

CT

DC

FL

GA

IL

IN

MO

NC

NE

NJ

NY

OH

TX

VA

WA