Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
Phase 3
220
about 4.3 years
10–17
26 sites in AL, AR, CA +16
About this study
Researchers are testing whether a treatment (OLZ/SAM vs olanzapine) affects weight gain, measured by changes in BMI Z-score, in children with schizophrenia or bipolar I disorder. The trial will last for 1553 days and involve approximately 220 participants.
Based on ClinicalTrials.gov records.
What participants do
- 1.Take OLZ/SAM
- 2.Take Olanzapine
Participation effort
Estimated from trial records. Details can vary by site.
Logistics difficulty varies by site location and availability.
Trial highlights
Treatment details
Auto-extracted from trial records to preview treatments and outcomes.
olanzapine
oral (Oral Tablet)
Primary: Change from baseline in body mass index (BMI) Zscore at week 12
Secondary: Change from baseline in Children's Depression Rating Scale-Revised (CDRS-R) for patients with bipolar I disorder by visit, Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score for patients with schizophrenia by visit, Change from baseline in Young Mania Rating Scale (YMRS) in patients with Bipolar I disorder, Change from baseline in waist circumference, Incidence of Adverse Events, Proportion of subjects with >=0.5 increase in BMI Z-score at Week 12
Psychiatry / Mental Health