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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

Study on weight changes in kids with schizophrenia or bipolar disorder.

Recruiting
10-17 years
All
Phase 3

This study looks at weight gain in children and teens with schizophrenia or bipolar I disorder. It compares the changes in body mass index (BMI) Z-score, a measure of weight adjusted for height, after treatment with two medications: OLZ/SAM and olanzapine. Participants should be between 10-17 years old, diagnosed according to the DSM-5 (a manual used to diagnose mental disorders), and have support from family or a legal guardian. They should not be a danger to themselves or others and must not have certain health conditions, like major depression or a history of seizures. Participants cannot have used certain medications, like opioids or long-acting antipsychotics, before the study.

  • The study involves taking medication and monitoring weight changes.
  • Participants must have a guardian for outpatient care.
  • Certain health conditions or recent medication use may exclude participation.
Study details
    Schizophrenia
    Bipolar I Disorder

NCT05303064

Alkermes, Inc.

13 April 2025

Step 1 Get in touch with the nearest study center
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