Phase 3 Study Comparing Weight Changes in Children and Teens With Schizophrenia or Bipolar I Disorder Using OLZSAM Versus Olanzapine

What this Trial Is About

This research aims to compare changes in body mass index BMI Z-score in children and adolescents with schizophrenia or bipolar I disorder who are treated with either a combination of olanzapine and samidorphan OLZSAM or olanzapine alone. The study focuses on evaluating weight gain differences between these treatments over time. The trial is a Phase 3, randomized, double-blind study sponsored by Alkermes, Inc., involving pediatric patients aged 10 to 17 years. Participants will be randomly assigned to receive either the fixed dose combination OLZSAM or olanzapine alone. The olanzapine starting dose will be 2.5 mgday or 5 mgday based on the Investigators decision, with a maximum dose of 20 mgday. Samidorphan will be given at a starting dose of 5 or 10 mg. The study duration is 52 weeks, during which participants will be monitored for changes in BMI Z-score and other health measures. During the study, participants will undergo evaluations including BMI measurements at baseline and week 12, waist circumference, and psychiatric assessments using scales like PANSS, YMRS, and CDRS-R. Researchers will also monitor adverse events and track treatment discontinuation over 52 weeks. The main outcome is the change in BMI Z-score at week 12, with additional assessments of symptom changes and safety throughout the study period.

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder