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Clinical trial

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)

NCT05303064 is registered in ClinicalTrials.gov with Alkermes, Inc. as lead sponsor.

NCT NCT05303064
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Registry record

As filed in ClinicalTrials.gov.

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)
Lead sponsor
Alkermes, Inc.
Phase
Phase 3
Overall status
Recruiting
Start date
June 30, 2022
Completion date
September 30, 2026
Enrollment
220 (estimated)
Sites
47

Conditions

As the registry lists them; a condition with its own page is linked.

bipolar i disorder, schizophrenia