Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Other: Therapeutic Drug Monitoring
* Other: Risperidone plasma level


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 6 to 18 years Documented clinical diagnosis of autism spectrum disorder according to DSM IV or DSM V and comorbid behavioural problems To start treatment with risperidone Exclusion Criteria: Diabetes type I or II Congenital or acquired syndrome associated with changes in appetite, body weight or lipid profile (e.g. Prader Willi) Treatment with antipsychotic medication within the last 6 months Known Long QT syndrome (LQTS) Pregnancy

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic Drug Monitoring<br>Physicians receive dosing advice based on measured blood levels of risperidone and 9-OH-risperidone. | Other: Therapeutic Drug Monitoring<br>* Physician receives dosing advice based on risperidone plasma level.<br>Other: Risperidone plasma level<br>* Plasma levels of risperidone and 9-OH risperidone are measured in a Dried Blood Spot.<br>|
| Active Comparator: Care As Usual<br>Physician decides on possible dosing changes without receiving advice based on blood levels. | Other: Risperidone plasma level<br>* Plasma levels of risperidone and 9-OH risperidone are measured in a Dried Blood Spot.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI z-score | Difference in body mass index z-scores 6 months after start of treatment. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 6 months | 
| Metabolic side effects (glucose) | Difference in level of glucose 6 months after start of treatment. | 6 months | 
| Metabolic side effects (cholesterol) | Difference in levels of cholesterol and lipoproteins (LDL, HDL) 6 months after start of treatment. | 6 months | 
| Metabolic side effects (triglycerides) | Difference in level of triglycerides 6 months after start of treatment. | 6 months | 
| Endocrine side effects (prolactin) | Difference in level of prolactin 6 months after start of treatment. | 6 months | 
| Extrapyramidal symptoms (EPS) | Difference in extrapyramidal symptoms measured by Abnormal Involuntary Movement Scale 6 months after start of treatment. | 6 months | 
| Endocrine side effects (ghrelin) | Difference in level of ghrelin 6 months after start of treatment. | 6 months | 
| Endocrine side effects (leptin) | Difference in level of leptin 6 months after start of treatment. | 6 months | 
| Side effects (blood pressure) | Difference in diastolic and systolic blood pressure 6 months after start of treatment. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Risperidone, Therapeutic Drug Monitoring