The National Institute of Mental Health (NIMH) is sponsoring a study into possible treatments for weight gain in children who take antipsychotic medications. Johns Hopkins University, the University of Maryland, the University of North Carolina, and the Zucker Hillside Hospital are collaborating on the study. The research is motivated by the high rates of metabolic disorders, particularly weight gain, experienced by children who are prescribed an antipsychotic medication.
The ill effects of metabolic changes and weight gain are chronic and result in increased sickness and health care costs. Children who grow up obese are at an even higher risk for myriad health issues. Currently, physicians must find the right balance between adequate treatment of a psychiatric condition and the potential side effects of increased body mass, higher cholesterol, and impaired organ function. The NIMH study will test two different treatments for weight management. Treatment 1 consists of a switch from the participant’s current medication to either Abilify (aripiprazole) or Trilafon (perphenazine). Treatment 2 consists of adding metformin to the participant’s current regimen of medication. Metformin is used to help maintain blood glucose levels, particularly in diabetic patients.
Eligibility requirements include a current diagnosis of a psychotic or severe mood disorder, ongoing prescription of an atypical antipsychotic medication, and a body mass index that places them in the 85th percentile for their age and gender. The atypical antipsychotics, also known as second-generation antipsychotics, are known to create problems with metabolism. Children and adolescents aged 8 to 19 years are eligible for the study. Exclusion criteria include substance abuse, diabetes, previous ineffectiveness of Abilify or Trilafon, and intolerance to metformin.
The study will last approximately six months. At the beginning and end of the study, children will be given a detailed physical exam and blood test. Body fat percentage, triglyceride level, and cholesterol level are some of the indicators that study doctors will measure. Each participant will be randomly assigned to one of the two treatment groups or the control group, which consists of no changes to the participant’s medication regimen. Regular clinic visits will assess progress, both in terms of psychiatric symptom and weight loss.
If either or both of the experimental treatments are successful, then it represents a tentative solution for metabolic conditions in children taking antipsychotics. In other studies, Abilify and Trilafon have effectively controlled psychotic symptoms while not causing weight gain. The current study will show whether those results translate to children as well.
U.S. National Institutes of Health, Clinical Trials. (n.d.). Reducing Weight Gain and Improving Metabolic Function in Children Being Treated With Antipsychotics. Retrieved July 25, 2012, from http://clinicaltrials.gov/ct2/show/NCT00806234?recr=Open&intr=%22Aripiprazole%22&rank=11
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