Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Sch… (NCT05303064) | Clinical Trial Compass
RecruitingPhase 3
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
United States220 participantsStarted 2022-06-30
Plain-language summary
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
Who can participate
Age range10 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Colum…
What they're measuring
1
Change from baseline in body mass index (BMI) Zscore at week 12