Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

Recruiting Phase 3 Interventional Study
Schizophrenia Bipolar I Disorder
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
10 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
220 (estimated)
Sponsor
Alkermes, Inc. · Industry
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About This Trial

To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine

Trial Locations
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Eligibility Criteria
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 …
Contacts

Global Clinical Services

888-235-8008 (US Only)

clinicaltrials@alkermes.com

CONTACT

Global Clinical Services

1-571-599-2702 (Global)

clinicaltrials@alkermes.com

CONTACT