clinical trial · NCT05303064
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
Alkermes, Inc.·phase3·recruiting·n = 220
SchizophreniaBipolar I DisorderOLZ/SAMOlanzapine
brief summary
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
started
Jun 30, 2022
primary completion
Sep 1, 2026
completion
Sep 1, 2026
last updated
Feb 18, 2026
official title
A Phase 3, Randomized, Double-Blind, 52-Week Study of OLZ/SAM vs Olanzapine to Evaluate Weight Gain as Assessed by Change in BMI Z-Score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder (ENLIGHTEN-Youth)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol