Metabolic Effects of Antipsychotics in Children

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Brief Title

Metabolic Effects of Antipsychotics in Children

Official Title

Metabolic Effects of Antipsychotics in Children

Brief 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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Change in DEXA % Body Fat

Secondary Outcome

 Change in Insulin-stimulated Glycerol Rate of Appearance (Glycerol Ra)

Condition

Aggression

Intervention

risperidone

Study Arms / Comparison Groups

 aripiprazole
Description:  Participants in this group will be randomized to flexibly-dosed treatment with aripiprazole.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

144

Start Date

April 2006

Completion Date

July 2011

Primary Completion Date

March 2011

Eligibility Criteria

        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)

          -  current substance abuse

          -  Past history or currently has dyskinesia

          -  Stimulant dosage significantly higher (per PI judgment)than the equivalent of
             approximately 2mg/kg/day methylphenidate equivalent dose.
      

Gender

All

Ages

6 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

John W. Newcomer, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00205699

Organization ID

NIMH

Secondary IDs

R01MH072912

Responsible Party

Sponsor

Study Sponsor

Washington University School of Medicine

Collaborators

 National Institute of Mental Health (NIMH)

Study Sponsor

John W. Newcomer, MD, Principal Investigator, Florida Atlantic University and Washington University School of Medicine


Verification Date

June 2018