trial

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

NCTId NCT05303064
as of 2026-07-01
Add to landscapeMonitor thisAsk about this
at a glance
Phase 3 · Recruiting
Enrollment 220 (estimated)
Sponsored by Alkermes, Inc.
Primary completion 2026-09
Synthesized from structured facts only — each point cited above.

Design & status

Phase
Phase 3
Status
Recruiting
Enrollment
220 (estimated)
Study type
Interventional
Allocation
Randomized
Model
Parallel
Masking
Quadruple
Start
2022-06-30
Primary completion
2026-09
Eligibility
ALL · 10 Years · 17 Years

Interventions & indications

Drugs
OLZ/SAMOlanzapine

Sponsors

Alkermes, Inc.Lead Sponsor

Investigators

1
David McDonnell, MDStudy Director

Sites

47 total
Dothan, United StatesLittle Rock, United StatesEncino, United StatesStanford, United StatesUpland, United StatesColorado Springs, United StatesDenver, United StatesHartford, United StatesWashington D.C., United StatesMiami, United StatesMiami Lakes, United StatesDecatur, United States

Linked catalysts

1
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric — primary completion2026-09

Facts & assertions

4 sourced
Enrollment
220
Phase
PHASE3
Primary Completion Date
2026-09
Status
RECRUITING
relationships
The graph out of here
drug
OLZ/SAM
drug
Olanzapine
drug
lead_sponsor
Alkermes, Inc.
company
indication
Schizophrenia
indication
Schizophrenia
indication
Bipolar I Disorder
indication
investigator
David McDonnell, MD
person