drugset / Trial / NCT05303064
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
Timeline
- Start
- 2022-06-30
- Primary completion
- 2026-09
- Completion
- 2026-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Olanzapine | Small molecule | 2.5 mg | — |
| Comparator | Olanzapine | Small molecule | 5 mg | — |
| Comparator | Olanzapine | Small molecule | 20 mg | — |
| Subject | Samidorphan | Small molecule | 5 mg | — |
| Subject | Samidorphan | Small molecule | 10 mg | — |