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
What this study is about
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.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take OLZ/SAM
- 2.Take Olanzapine
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
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