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Metabolic Effects of Antipsychotics in Children | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Metabolic Effects of Antipsychotics in Children

NCT00205699•Washington University School of Medicine

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.

Eligibility

Age

6 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged 6-18 years
•Generally healthy and a score of ≥ 18 on the Aberrant Behavior Checklist in the context of one or more Axis I Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) childhood psychiatric disorders, including conduct disorder, oppositional defiant disorder, disruptive behavior disorder, autism, pervasive developmental disorder, attention deficit disorder, schizophrenia and bipolar affective disorders
•Children's Global Assessment Scale (CGAS) score ≤ 60
•Not previously treated with an antipsychotic; individual subjects with remote, brief prior antipsychotic exposure may be considered for enrollment by the PI on a case by case basis
•Patient assent and informed consent obtained from the parent or guardian
•No clinically significant (based on PI determination) changes in permitted medications (e.g., stimulants and selective serotonin reuptake inhibitors \[SSRIs\]) for approximately 1 month prior to Baseline evaluations

Exclusion Criteria

•Active suicidality or primary dx of major depressive disorder
•Any lifetime use of antipsychotics or non-serotonin selective reuptake inhibitor (non-SSRI) anti-depressants
•The presence of any serious medical disorder, based on PI determination, that may confound the assessment of relevant biologic measures or diagnoses, including:
•* significant organ system dysfunction;
•* endocrine disease, including type 1 or type 2 diabetes mellitus;
•* coagulopathy;
•* anemia;
•* or acute infection.
•Subjects regularly taking any glucose lowering agent, lipid lowering agent, exogenous testosterone, recombinant human growth hormone, or any other endocrine agent that might confound substrate metabolism, oral glucocorticoids (glucocorticoid inhalants and nasal sprays are permitted), antihistamines, sedating antihistamines (non-sedating antihistamines such as but not limited to Claritin (loratadine) and Zyrtec (cetirizine) are permitted), and certain mood stabilizing agents, as some medications may themselves worsen or otherwise alter weight gain, glucose and lipid regulation or otherwise make it difficult to assess the effects of the antipsychotic alone; (note that exposure to many psychotropic agents including stimulants and SSRI's is permitted in order to maintain the generalizability of the sample);
•Intelligence quotient (IQ) \< 70 (based on school records and/or evaluation by clinician)
+3 more criteria

Locations (1)

Washington University School of Medicine, Psychiatry Dept.

St Louis, Missouri, United States

Key Dates

Start Date

April 1, 2006

Primary Completion Date

March 1, 2011

Completion Date

July 1, 2011

Last Updated

June 15, 2018

Enrollment

144

ACTUAL participants

Conditions

AggressionAttention Deficit-HyperactivityOppositional Defiant DisorderPervasive Development DisordersBipolar Disorder

Interventions

risperidone

DRUG

olanzapine

DRUG

aripiprazole

DRUG

ACTsocially: The (Dis)Similarities of ACT for Changing Internalizing and Externalizing Symptomatology in Adolescence

NCT07456631

Social Anxiety Disorder (SAD)Oppositional Defiant Disorder

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RECRUITINGPHASE1/PHASE2

Pathways 2 Success

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Conduct DisorderOppositional Defiant Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 15, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Metabolic Effects of Antipsychotics in Children

Inclusion Criteria

Exclusion Criteria

ACTsocially: The (Dis)Similarities of ACT for Changing Internalizing and Externalizing Symptomatology in Adolescence

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