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)
Status: Recruiting
Location: See all (47) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 17
Healthy Volunteers: f
View:
• Subjects aged 13 to 17 years with schizophrenia or aged 10 to 17 years with bipolar I disorder, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
• Subject is an outpatient or will be able to be treated on an outpatient basis (per Investigator judgement) by study Week 2
• Subject has reliable family/legal guardian support available for outpatient management
• Subject is either currently treated with olanzapine, or if treated with another antipsychotic, the subject has had an inadequate response (eg, unsatisfactory clinical response, AEs, or nonadherence to current medication) based on Investigator judgment
• Subject must not be a danger to self or others (per Investigator judgement)
Locations
United States
Alabama
Alkermes Investigator Site
RECRUITING
Dothan
Arkansas
Alkermes Investigator Site
RECRUITING
Little Rock
California
Alkermes Investigator Site
WITHDRAWN
Encino
Alkermes Investigator Site
RECRUITING
Stanford
Alkermes Investigator Site
WITHDRAWN
Upland
Colorado
Alkermes Investigator Site
WITHDRAWN
Colorado Springs
Alkermes Investigator Site
RECRUITING
Denver
Connecticut
Alkermes Investigator Site
WITHDRAWN
Hartford
Washington, D.c.
Alkermes Investigator Site
RECRUITING
Washington D.c.
Florida
Alkermes Investigator Site
WITHDRAWN
Miami
Alkermes Investigator Site
RECRUITING
Miami Lakes
Georgia
Alkermes Investigator Site
RECRUITING
Decatur
Illinois
Alkermes Investigator Site
RECRUITING
Chicago
Indiana
Alkermes Investigator Site
RECRUITING
Indianapolis
Missouri
Alkermes Investigator Site
RECRUITING
Saint Charles
North Carolina
Alkermes Investigational Site
WITHDRAWN
Kinston
Nebraska
Alkermes Investigator Site
RECRUITING
Lincoln
Alkermes Investigator Site
WITHDRAWN
Omaha
New Jersey
Alkermes Investigator Site
NOT_YET_RECRUITING
Paramus
New York
Alkermes Investigator Site
NOT_YET_RECRUITING
New York
Ohio
Alkermes Investigator Site
RECRUITING
Cincinnati
Alkermes Investigator Site
RECRUITING
West Chester
Texas
Alkermes Investigator Site
TERMINATED
Desoto
Alkermes Investigator Site
RECRUITING
Fort Worth
Virginia
Alkermes Investigational Site
RECRUITING
Richmond
Washington
Alkermes Investigator Site
RECRUITING
Everett
Other Locations
Argentina
Alkermes Investigator Site
RECRUITING
Buenos Aires
Alkermes Investigator Site
RECRUITING
Córdoba
Alkermes Investigator Site
RECRUITING
La Plata
Alkermes Investigator Site
RECRUITING
La Plata
Alkermes Investigator Site
RECRUITING
Mendoza
Brazil
Alkermes Investigator Site
RECRUITING
Curitiba
Alkermes Investigator Site
RECRUITING
Fortaleza
Alkermes Investigator Site
RECRUITING
Goiânia
Alkermes Investigator Site
RECRUITING
Rio De Janeiro
Alkermes Investigator Site
RECRUITING
São Paulo
Alkermes Investigator Site
RECRUITING
São Paulo
Colombia
Alkermes Investigator Site
RECRUITING
Barranquilla
Alkermes Investigator Site
RECRUITING
Bello
Alkermes Investigator Site
RECRUITING
Bogotá
Alkermes Investigator Site
RECRUITING
Bogotá
Alkermes Investigator Site
RECRUITING
Pereira
Mexico
Alkermes Investigator Site
RECRUITING
Culiacán
Alkermes Investigator Site
RECRUITING
Estado De México
Alkermes Investigator Site
RECRUITING
León
Alkermes Investigator Site
RECRUITING
Monterrey
Alkermes Investigator Site
RECRUITING
Monterrey
Contact Information
Primary
Global Clinical Services
clinicaltrials@alkermes.com
888-235-8008 (US Only)
Backup
Global Clinical Services
clinicaltrials@alkermes.com
1-571-599-2702 (Global)
Time Frame
Start Date:2022-06-30
Estimated Completion Date:2026-09
Participants
Target number of participants:220
Treatments
Experimental: Group 1 OLZ/SAM
Fixed dose combination of olanzapine and samidorphan