At a glance
ClinicalIndex Comparison Record- ✓Aged 6-18 years
- ✓Behavioral or psychiatric disorder with Aberrant Behavior Checklist score ≥18 (conduct disorder, oppositional defiant disorder, disruptive behavior disorder, autism, pervasive developmental disorder, attention deficit disorder, schizophrenia, or bipolar affective disorder)
- ✓Children's Global Assessment Scale (CGAS) score ≤60
- ✓Antipsychotic-naive or minimal prior exposure (remote, brief use may be considered case-by-case by PI)
- ✕Active suicidality or primary diagnosis of major depressive disorder
- ✕Any lifetime use of antipsychotics or non-SSRI antidepressants
- ✕Serious medical disorder (organ dysfunction, endocrine disease including diabetes, coagulopathy, anemia, or acute infection)
- ✕Medications that confound metabolic assessment: glucose-lowering agents, lipid-lowering agents, exogenous testosterone, recombinant growth hormone, endocrine agents, systemic glucocorticoids, sedating antihistamines, or certain mood stabilizers
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Metabolic Effects of Antipsychotics in Children
In Brief
A Phase 4 clinical trial evaluating risperidone, olanzapine, and 1 other intervention for Aggression and 4 related conditions. Completed, enrolled 144 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
randomized to begin 12 week trial of risperidone
randomized to begin 12 week trial of olanzapine
randomized to 12 week trial of aripiprazole