Bipolar Disorder Clinical Trial
Official title:
Metabolic Effects of Antipsychotics in Children
The project aims to describe and compare the outcome of 12 weeks of prospective, randomized treatment with olanzapine, risperidone or aripiprazole on insulin action in skeletal muscle, liver and adipose tissue, abdominal fat mass, total body and fat-free mass, efficacy for symptoms of aggression and non-metabolic adverse events. Children aged 6-18 will be studied, exploring effects of stimulant therapy and age-related differences in vulnerability to treatment-induced adverse metabolic changes. Aims are addressed by measuring glucose and lipid kinetics with stable isotope tracers, body composition with dual energy x-ray absorptiometry and magnetic resonance imaging (MRI), and standardized assessments of efficacy and adverse events. Relevant data are critically needed to target clinical therapy and basic research, identify medical risks, and guide regulatory decisions in this vulnerable population.
This randomized clinical trial assesses both the safety and efficacy of atypical
antipsychotic agents in antipsychotic-naive aggressive children with various childhood
psychiatric disorders during 12 weeks of prospective, randomized treatment with olanzapine,
risperidone or aripiprazole.
Aim 1: To evaluate effects of selected antipsychotic treatments on insulin action in muscle
(glucose disposal), liver (glucose production) and adipose tissue (lipolysis).
Aim 2: To evaluate effects of selected antipsychotic treatments on abdominal fat mass, total
body fat and total fat-free mass.
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