Clinical Trial

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

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
Protocol Amendment History 20 amendments
This ClinicalTrials.gov record has been amended 20 times since 2022-03-22; most recent amendment 2026-06-02.
Status change: Not Yet Recruiting → Recruiting 2022-07-06
Trial Details
NCT Number NCT05303064
Lead Sponsor Alkermes, Inc.
Conditions Schizophrenia, Bipolar I Disorder
Enrollment 220 participants
Start Date 2022-06-30
Primary Completion 2026-09 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-14