Ignite Creation Date:
2024-05-06 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05303064
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2022-03-22
Brief Title:
Study to Evaluate Weight Gain As Assessed by Change in BMI Z-score in Pediatric Subjects with Schizophrenia or Bipolar I Disorder
Sponsor:
Alkermes Inc
Organization:
Alkermes Inc
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind 52-Week Study of OLZSAM 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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare changes in body mass index BMI Z-score following treatment with OLZSAM vs olanzapine
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None