Metabolic Effects of Antipsychotics in Children
| Status: | Completed |
|---|---|
| Conditions: | Cognitive Studies, Psychiatric, Psychiatric, ADHD, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 6 - 18 |
| Updated: | 6/17/2018 |
| Start Date: | April 2006 |
| End Date: | July 2011 |
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.
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.
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.
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.
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