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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.
Summary
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
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)
Key Details
Gender
All
Age Range
10 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2022-06-30
Completion Date
2026-09
Last Updated
2026-02-18
Healthy Volunteers
No
Conditions
Interventions
OLZ/SAM
OLZ/SAM refers to the fixed dose combination of olanzapine and samidorphan. The starting dose of olanzapine will be 2.5 mg/day or 5 mg/day at the discretion of the Investigator with a maximum daily dose of 20mg/day. The starting dose of samidorphan will be 5 or 10 mg.
Olanzapine
The starting dose of olanzapine will be 2.5 mg/day or 5 mg/day at the discretion of the Investigator with a maximum daily dose of 20mg/day
Locations (47)
Alkermes Investigator Site
Dothan, Alabama, United States
Alkermes Investigator Site
Little Rock, Arkansas, United States
Alkermes Investigator Site
Encino, California, United States
Alkermes Investigator Site
Stanford, California, United States
Alkermes Investigator Site
Upland, California, United States
Alkermes Investigator Site
Colorado Springs, Colorado, United States
Alkermes Investigator Site
Denver, Colorado, United States
Alkermes Investigator Site
Hartford, Connecticut, United States
Alkermes Investigator Site
Washington D.C., District of Columbia, United States
Alkermes Investigator Site
Miami, Florida, United States
Alkermes Investigator Site
Miami Lakes, Florida, United States
Alkermes Investigator Site
Decatur, Georgia, United States
Alkermes Investigator Site
Chicago, Illinois, United States
Alkermes Investigator Site
Indianapolis, Indiana, United States
Alkermes Investigator Site
Saint Charles, Missouri, United States
Alkermes Investigator Site
Lincoln, Nebraska, United States
Alkermes Investigator Site
Omaha, Nebraska, United States
Alkermes Investigator Site
Paramus, New Jersey, United States
Alkermes Investigator Site
New York, New York, United States
Alkermes Investigational Site
Kinston, North Carolina, United States
Alkermes Investigator Site
Cincinnati, Ohio, United States
Alkermes Investigator Site
West Chester, Ohio, United States
Alkermes Investigator Site
DeSoto, Texas, United States
Alkermes Investigator Site
Fort Worth, Texas, United States
Alkermes Investigational Site
Richmond, Virginia, United States
Alkermes Investigator Site
Everett, Washington, United States
Alkermes Investigator Site
La Plata, Buenos Aires, Argentina
Alkermes Investigator Site
La Plata, Buenos Aires, Argentina
Alkermes Investigator Site
Buenos Aires, Argentina
Alkermes Investigator Site
Córdoba, Argentina
Alkermes Investigator Site
Mendoza, Argentina
Alkermes Investigator Site
Fortaleza, Ceará, Brazil
Alkermes Investigator Site
Curitiba, Paraná, Brazil
Alkermes Investigator Site
Goiânia, Brazil
Alkermes Investigator Site
Rio de Janeiro, Brazil
Alkermes Investigator Site
São Paulo, Brazil
Alkermes Investigator Site
São Paulo, Brazil
Alkermes Investigator Site
Barranquilla, Colombia
Alkermes Investigator Site
Bello, Colombia
Alkermes Investigator Site
Bogotá, Colombia
Alkermes Investigator Site
Bogotá, Colombia
Alkermes Investigator Site
Pereira, Colombia
Alkermes Investigator Site
Culiacán, Mexico
Alkermes Investigator Site
Estado de México, Mexico
Alkermes Investigator Site
León, Mexico
Alkermes Investigator Site
Monterrey, Mexico
Alkermes Investigator Site
Monterrey, Mexico