Baylor College of Medicine

Long-term Antipsychotic Pediatric Safety Trial (H-43567)

Description

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What are the long-term side-effects of antipsychotic medications?

Content

Antipsychotic medications are often used to treat mood swings, aggression, and sometimes psychosis. These medications are quite effective but can also cause side effects, such as weight gain. This study focuses on two antipsychotics: risperidone (Risperdal) and aripiprazole (Abilify). In this study, we hope to learn about changes in health, including weight, and quality of life in children and adolescents who are taking one of these two medications. This study is carried out across many sites in the USA and is funded by the National Institutes of Health. 

What does the study entail? 

  • Five in-person visits at our clinic and monthly online check-ins. Each in-person visit lasts about 1-2 hours and the online check-ins last about five minutes.
  • Study participation will last for two years.
  • At each visit, participants will be asked to complete questionnaires and a brief physical exam. At every other visit, participants will undergo an optional fasting blood draw. The results are shared with the family and the health care provider who is prescribing the antipsychotic medication. 
  • Participants will be compensated $25-$250 depending on how much of the study they complete, in addition to receiving a copy of any bloodwork completed.

Study requirements 

  • Must be 3-17 years of age.
  • Currently taking risperidone (Risperdal) or aripiprazole (Abilify) for autism, psychosis, bipolar disorder, or tics.
  • No major medical conditions.

IRB: H-43567

Status:

Active

Created:

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