Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects
Enrolling by invitation · Phase 3 · NCT04987229
Conditions: Bipolar I Disorder, Schizophrenia
At a glance
- Research payments reported, 2025
- $1.4M
- U.S. investigators named
- 23
- Sites paid
- 22
- Planned or actual enrollment
- 236
About the trial
- Sponsor
- Alkermes, Inc.
- Tested
- OLZ/SAM (drug)
- Dates
- Started 2021-10-22; completion 2027-09
- Results posted
- Not yet
To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder
From ClinicalTrials.gov, last updated 2026-08-14. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Alkermes, Inc. reported $1.4M in research payments for this study in 2025 (280 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
- Jacob S. Ballon, MD Psychiatry · Palo Alto, CA
- Austina B. Cho, M.D. Psychiatry · Orange, CA
- Clifford R. Feldman, M.D, J.D., M.F.S. Psychiatry · Tarzana, CA
- Andrew Sedillo, MD Psychiatry · Aurora, CO
- Deborah A. York, NP Psychiatric Nurse Practitioners · Denver, CO
- Benjamin J. Anderson, MD Child & Adolescent Psychiatry · Hartford, CT
- 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
- 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
- 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 $459,444
- Alivation Research, LLC. $207,441
- UC Healthcare System $93,392
- Ann & Robert H Lurie Childrens Hospital of Chicago, IL $73,363
- Virginia Commonwealth University $50,888
- Children's Research Institute $46,789
- Une Health $46,710
- Mountain Mind, LLC. $39,975
- Cincyscience $39,477
- Harmonex, Inc. $36,463
- Cenexel Iresearch LLC $33,561
- Wr-Pri, LLC. $33,133
- The Board of Trustees of the Leland Stanford Junior University $27,540
- Mcb Clinical Research Centers LLC $22,358
- John Peter Smith Foundation $21,733
- Berma Research Group - Atlanta, LLC. $20,883
- St. Charles Psychiatric Associates $19,633
- Hartford Hospital, CT $19,633
- Insite Clinical Research, LLC. $19,633
- Advanced Research Center, Inc. $19,633
- Pillar Clinical Research, LLC. $10,542
- Eastside Therapeutic Resource, Inc. dba Core Clinical Research $7,907
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.