MedTrace Logo

Metabolic Effects of Antipsychotics in Children

NCT00205699 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2018-06-15

Study results available
· View outcomes & findings →

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • John W. Newcomer, MD · Florida Atlantic University and Washington University School of Medicine

  • Ginger Nicol, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2011-03-31
Completion
2011-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00205699 on ClinicalTrials.gov