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)
Alkermes, Inc.
Summary
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
Eligibility
- Age range
- 10–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugOLZ/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.
- DrugOlanzapine
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 SiteDothan, Alabama
- Alkermes Investigator SiteLittle Rock, Arkansas
- Alkermes Investigator SiteEncino, California
- Alkermes Investigator SiteStanford, California
- Alkermes Investigator SiteUpland, California
- Alkermes Investigator SiteColorado Springs, Colorado