A new federally funded study will examine ways to control the metabolic side effects associated with the use of the newer atypical antipsychotic medications in children with schizophrenia or bipolar disorder.
The use of atypical antipsychotic medications to treat children and adolescents with schizophrenia or bipolar disorder is relatively common, but the side effects associated with them are troubling.
The recent NIMH-funded Treatment of Early Onset Schizophrenia Study (TEOSS) found that two atypical medications were associated with more metabolic side effects than an older generation antipsychotic.
The new grant will test ways in which the metabolic side effects, such as weight gain, insulin sensitivity and other factors that can lead to type 2 diabetes and heart disease, may be controlled or reduced.
Physicians from Johns Hopkins University the University of North Carolina Chapel Hill, and the Feinstein Institute for Medical Research in New York, will recruit 240 overweight youths ages 8 to 17 who have been diagnosed with schizophrenia or bipolar disorder, who are currently being treated with risperidone (Risperdal), quetiapine (Seroquel) or olanzapine (Zyprexa), and who have gained at least 10 percent of their baseline body weight over the past year of treatment. The youths will be randomly assigned to one of three conditions:
• Add metformin—a medication used to treat type 2 diabetes—to their current medication;
• Switch to aripiprazole (Abilify), another type of atypical antipsychotic;
• Continue with their current medication (control group).
All of the participants will be closely monitored and provided with advice about healthy lifestyle, diet and exercise. The children and adolescents will be evaluated over a 24-week period to determine changes in weight, insulin sensitivity, and other metabolic factors.
The researchers will also track the youths’ psychiatric symptoms, quality of life, and other side effects, and will track whether and when they discontinue treatment.
The researchers anticipate that the study’s results will help determine better treatment options for children and adolescents with major psychiatric disorders who need long term treatment with antipsychotics.