The aim of this study is to test whether therapeutic drug monitoring of risperidone in children with autism spectrum disorder and comorbid behavioral problems is able to reduce metabolic side effect burden, while retaining clinical effectiveness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
140
Physician receives dosing advice based on risperidone plasma level.
Plasma levels of risperidone and 9-OH risperidone are measured in a Dried Blood Spot.
Erasmus Medical Center
Rotterdam, Netherlands
RECRUITINGBMI z-score
Difference in body mass index z-scores 6 months after start of treatment.
Time frame: 6 months
Effectivity (ABC)
Difference on the Irritability scale of the Aberrant Behavior Checklist (scores ranging from 0 to 45, a higher score means more symptoms) 6 months after start of treatment.
Time frame: 6 months
Effectivity (CGI)
Difference on the Clinical Global Impression scale (scores ranging from 1 to 7, a higher score means higher severity) 6 months after start of treatment.
Time frame: 6 months
Quality of Life (PedsQL)
Difference on Pediatric Quality of Life Inventory (scores ranging from 0 to 100, a higher score indicates a better quality of life) 6 months after start of treatment.
Time frame: 6 months
Metabolic side effects (glucose)
Difference in level of glucose 6 months after start of treatment.
Time frame: 6 months
Metabolic side effects (cholesterol)
Difference in levels of cholesterol and lipoproteins (LDL, HDL) 6 months after start of treatment.
Time frame: 6 months
Metabolic side effects (triglycerides)
Difference in level of triglycerides 6 months after start of treatment.
Time frame: 6 months
Endocrine side effects (prolactin)
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Difference in level of prolactin 6 months after start of treatment.
Time frame: 6 months
Extrapyramidal symptoms (EPS)
Difference in extrapyramidal symptoms measured by Abnormal Involuntary Movement Scale 6 months after start of treatment.
Time frame: 6 months
Endocrine side effects (ghrelin)
Difference in level of ghrelin 6 months after start of treatment.
Time frame: 6 months
Endocrine side effects (leptin)
Difference in level of leptin 6 months after start of treatment.
Time frame: 6 months
Side effects (blood pressure)
Difference in diastolic and systolic blood pressure 6 months after start of treatment.
Time frame: 6 months