NCT00205699

Metabolic Effects of Antipsychotics in Children

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Aggression
• Attention Deficit-Hyperactivity
• Oppositional Defiant Disorder
• Pervasive Development Disorders
• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	risperidone	randomized to begin 12 week trial of risperidone
DRUG	olanzapine	randomized to begin 12 week trial of olanzapine
DRUG	aripiprazole	randomized to 12 week trial of aripiprazole

Timeline

• Start date: 2006-04-01
• Primary completion: 2011-03-01
• Completion: 2011-07-01
• First posted: 2005-09-20
• Last updated: 2018-06-15
• Results posted: 2018-06-15

Locations

1 site across 1 country: United States