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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 how a medicine called OLZ/SAM affects weight gain in kids and teens with schizophrenia or bipolar I disorder. Schizophrenia is a mental disorder causing people to have trouble thinking clearly, while bipolar I disorder causes mood swings. The study checks the body mass index (BMI), which tells if a person is underweight, normal weight, or overweight, using a special score called the BMI Z-score.

  • The study is for kids aged 10 to 17 who meet criteria for schizophrenia or bipolar I disorder.
  • Participants must have support from family or a guardian and be treated as outpatients.
  • Those currently taking olanzapine or who didn't respond well to other medicine can join.

Participants cannot join if they have other major mental health issues, a history of seizures, or certain medical conditions. They also can't join if they recently used specific medicines like opioids or received long-lasting antipsychotic shots. The study wants to see if OLZ/SAM helps control weight better than olanzapine alone, so it checks if participants have too high or too low BMI percentiles or diabetes. This study will help doctors understand weight effects of these medicines better.

Study details
    Schizophrenia
    Bipolar I Disorder

NCT05303064

Alkermes, Inc.

9 February 2025

Step 1 Get in touch with the nearest study center
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