RecruitingNCT05303064
Weight changes with olanzapine-samidorphan or olanzapine in young people with schizophrenia or bipolarity
About this title
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
Read the official source — NCT05303064Medication studyAges 10–17Multiple countries
Understand this study
Who could participate?
Listed age limits: 10 years to 17 years.
What will I do during this study?
Children and adolescents are assigned to olanzapine or a fixed-dose combination of olanzapine and samidorphan. The public record reviewed does not specify the treatment duration or visit schedule.
- Listed locations
- Dothan and 46 more locationsSee all locations and recruitment
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
What to know before participating
A point to clarify
This summary does not cover all risks or eligibility requirements. What risks or changes to my care would apply to me?
Things to check before joining
Study start dateStarted: June 30, 2022
- Recruitment status
- Recruiting
- Enrollment listed in the registry
- 220
- Sponsor
- Alkermes, Inc.
- Sponsor type
- Other organization
- Study type
- Drug
- Intervention type
- Drug
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
- Locations
- United States, Argentina, Brazil, ...
- Age range
- From 10 Years to 17 Years
- Official registry ID
- NCT05303064
- Official title
Show the full official 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)
Recruitment & locations
Currently recruitingA study may be recruiting, but some locations may no longer be accepting participants. Confirm availability with the research team.
Dothan, United States · Little Rock, United States · Encino, United States
40 more locations
- Stanford, United States
- Upland, United States
- Colorado Springs, United States
- Denver, United States
- Hartford, United States
- Washington D.C., United States
- Miami, United States
- Miami Lakes, United States
- Decatur, United States
- Chicago, United States
- Indianapolis, United States
- Saint Charles, United States
- Lincoln, United States
- Omaha, United States
- Paramus, United States
- New York, United States
- Kinston, United States
- Cincinnati, United States
- West Chester, United States
- DeSoto, United States
- Fort Worth, United States
- Richmond, United States
- Everett, United States
- La Plata, Argentina
- Buenos Aires, Argentina
- Córdoba, Argentina
- Mendoza, Argentina
- Fortaleza, Brazil
- Curitiba, Brazil
- Goiânia, Brazil
- Rio de Janeiro, Brazil
- São Paulo, Brazil
- Barranquilla, Colombia
- Bello, Colombia
- Bogotá, Colombia
- Pereira, Colombia
- Culiacán, Mexico
- Estado de México, Mexico
- León, Mexico
- Monterrey, Mexico
Interested in joining this study?
Questions about this study
Who is behind this study?
The study sponsor is Alkermes, Inc.
Does this study involve medication?
Yes. The study involves medication, including OLZ/SAM and Olanzapine.
Who can participate?
Listed age limits: 10 years to 17 years.
Is this study still recruiting?
The registry lists this study as recruiting.
