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RECRUITING
NCT05303064
PHASE3

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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