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 · NCT05303064
Conditions: Schizophrenia, Bipolar I Disorder
At a glance
- Research payments reported, 2025
- $1.7M
- U.S. investigators named
- 26
- Sites paid
- 24
- Planned or actual enrollment
- 220
About the trial
- Sponsor
- Alkermes, Inc.
- Tested
- OLZ/SAM (drug), Olanzapine (drug)
- Dates
- Started 2022-06-30; completion 2026-09
- Results posted
- Not yet
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
From ClinicalTrials.gov, last updated 2026-08-14. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Alkermes, Inc. reported $1.7M in research payments for this study in 2025 (439 payments).
Products named: Lybalvi
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Nelson Handal, M.D. Child & Adolescent Psychiatry · Dothan, AL
- Leslie G. Smith, M.D. Psychiatry · Little Rock, AR
- Jacob S. Ballon, MD Psychiatry · Palo Alto, CA
- Clifford R. Feldman, M.D, J.D., M.F.S. Psychiatry · Tarzana, CA
- Robert B. Imani, M.D. Psychiatry · Lancaster, CA
- Rebecca A. Kornbluh, M.D. Psychiatry · Pomona, CA
- Andrew Sedillo, MD Psychiatry · Aurora, CO
- Deborah A. York, NP Psychiatric Nurse Practitioners · Denver, CO
- Adelaide Robb, MD Neurology · Washington, DC
- Durim Bozhdaraj, M.D. Psychiatry · Miami, FL
- Junior W. Pittack, MD Psychiatry · Hialeah, FL
- Kimball A. Johnson, MD Internal Medicine · Atlanta, GA
- Leslie A. Hulvershorn, MD Psychiatry · Indianapolis, IN
- Gregory W. Mattingly, M.D. Psychiatry · Saint Charles, MO
- Punitha I. Rathnam, M.D. Psychiatry · Goldsboro, NC
- Walter J. Duffy, MD Psychiatry · Lincoln, NE
- Tapan Parikh Psychiatry · Camden, NJ
- Ekaterina A. Stepanova, MD Psychiatry · Reno, NV
- Soonjo Hwang, M.D. Psychiatry · Valhalla, NY
- Mohamed Abdel Aziz, MD Psychiatry · West Chester, OH
- Melissa P. Delbello, MD Child & Adolescent Psychiatry · Cincinnati, OH
- Katarzyna Liwski, D.O. Psychiatry · Philadelphia, PA
- Dustin S. Demoss, DO Psychiatry · Fort Worth, TX
- Rajinder Shiwach, MD Psychiatry · Desoto, TX
- Leslie W. Smith, MD Psychiatry · Fort Worth, TX
- James A. Knutson, M.D. Prescribing Psychologist · Kirkland, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Elias Research Associates, LLC $404,369
- Alivation Research, LLC. $292,644
- Pillar Clinical Research, LLC. $161,216
- UC Healthcare System $89,425
- Ann & Robert H Lurie Childrens Hospital of Chicago, IL $84,574
- Cenexel Iresearch LLC $71,696
- Mountain Mind, LLC. $64,821
- Virginia Commonwealth University $63,987
- Harmonex, Inc. $48,560
- Cincyscience $44,454
- Pacific Clinical Research Medical Group $37,849
- Children's Research Institute $36,573
- Une Health $35,545
- St. Charles Psychiatric Associates $32,849
- Wr-Pri, LLC. $30,657
- Trustees of Indiana University $27,699
- Mcb Clinical Research Centers LLC $24,944
- Om Research, LLC. $20,282
- New York Univer. Medical Ctr. $18,779
- The Board of Trustees of the Leland Stanford Junior University $18,055
- Eastside Therapeutic Resource, Inc. dba Core Clinical Research $15,085
- John Peter Smith Foundation $14,892
- Berma Research Group - Atlanta, LLC. $10,852
- Insite Clinical Research, LLC. $5,197
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.