The purpose of this study is to learn more about weight gain and related side effects when children are treated with antipsychotic medicine for mood disorders.
This protocol is a six month, randomized, open label trial of risperidone versus aripiprazole in antipsychotic naive youth (7 - 12 years old) who have been identified by their clinical treatment provider as needing antipsychotic treatment of a bipolar disorder. This study proposes to monitor changes in metabolic parameters (body mass index percentile, % body fat, insulin resistance, and lipid levels) over the course of six months treatment with aripiprazole or risperidone in youth with a bipolar spectrum disorder. We will also assess possible mechanisms of second generation antipsychotic induced weight gain by monitoring physical activity and hunger/appetite changes over the course of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
5
Children will have a flexible dose titration based on their unique response to the medication (assessed using clinical global improvement scores). Children will be treated for six months using daily, bid dosing.
children will have a flexible dosing titration based on their unique response (assessed using clinical global improvement scores). Children will be treated with daily medication for six months.
University of Maryland, School of Medicine, Department of Psychiatry, Division of Child and Adolescent Psychiatry
Baltimore, Maryland, United States
Weight Gain
Weight gain from baseline to last observation up to 12 weeks. Last observation carried to 12 weeks.
Time frame: These measurements are done biweekly from baseline up until 12 weeks
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