Metabolic Effects of Antipsychotics in Children (Treatment Study)
Reference Number: 201108169
WHAT IS THE PURPOSE OF THE STUDY?
Use of antipsychotic medication in children and young adults has been shown to be an effective treatment for behaviors such as aggression, but doctors don't know as much about how they may affect weight, glucose, insulin, and lipids in younger patients. The point of this research is to study side effects of FDA-approved antipsychotic medications. These medications are now used commonly in children and young adults who have conduct disorder, aggression or other behavioral symptoms, although they are not FDA-approved for this purpose. We will be measuring how these drugs affect body weight and substances in the body such as glucose (sugar), insulin (a hormone that controls blood sugar levels), and lipids (fats). Dr. Newcomer and colleagues have performed more than 400 studies of this kind in adults to look at how different types of antipsychotic medications affect weight, glucose, insulin, and lipids. This study will include 264 children and young adults whose doctors want them to start taking antipsychotic medications to treat conduct disorder or other behavior symptoms.
WHO IS NEEDED?
Children with behavior problems and no history of diabetes.
WHAT IS INVOLVED IF I PARTICIPATE?
Duration: Approximately 13 weeks.
Tests/Procedures: Participation Involves:
-A screening visit at Barnes Hospital.
-Glucose tolerance tests at Barnes Hospital.
-DXA scan (to measure body fat and content)
-Children will be asked questions about how you feel.
-MRI of the abdomen (to measure fat and content)
-Two one day testing visits at Children's Hospital.
-Willingness to try a different medication under the supervision of your doctor.
-Regular check-ups with the research team.
Risks: Will be discussed in detail at the screening visit.
Benefits: These medicines may improve symptoms associated with aggressive behavior or conduct disorder. In addition, participants will be checked for serious medical conditions that may not show any symptoms, such as high blood pressure or diabetes. Finding these conditions may improve medical care.
This study will help doctors to understand how certain medications may affect diabetes risk and ways to address the risk of diabetes in children with conduct disorder, aggression or other behavior problems.
Compensation: Participants will receive a total value of $880.00 combined in gift certificates/Savings Bonds/and monetary reimbursement for participation in this research study. Remuneration will be distributed with the parent/ guardian receiving less than half of the total amount in cash. Children will receive payment in their choice of gift certificates or savings bonds. If a participant would like to stop their participation at any time, they will receive part of the $880 value, based on how far in the study they are ($180 for the screening visit, $100 for each the three OGTTs, and $200 for each of the two Isotope Clamps). All compensation will be for time and inconvenience for both the parent(s) and child.
WHO IS THE PRINCIPAL INVESTIGATOR (DOCTOR)?
John Newcomer, M.D.
Associate Professor of Psychiatry
WHERE WILL THE STUDY TAKE PLACE?
Children's or Barnes Hospital
Clinical Research Coordinator