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

Phase 4

Recruiting

• Conditions: Autism Spectrum Disorder
• Interventions: Other: Therapeutic Drug Monitoring; Other: Risperidone plasma level

• Registration Number: NCT05146245
• Lead Sponsor: Erasmus Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-11-23
• Study Start: 2021-12-01
• Study First Posted: 2021-12-06
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-08
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic Drug Monitoring	Therapeutic Drug Monitoring	Physicians receive dosing advice based on measured blood levels of risperidone and 9-OH-risperidone.
Care As Usual	Risperidone plasma level	Physician decides on possible dosing changes without receiving advice based on blood levels.
Therapeutic Drug Monitoring	Risperidone plasma level	Physicians receive dosing advice based on measured blood levels of risperidone and 9-OH-risperidone.

Primary Outcome Measures

Name	Time	Method
BMI z-score	6 months	Difference in body mass index z-scores 6 months after start of treatment.

Secondary Outcome Measures

Name	Time	Method
Metabolic side effects (triglycerides)	6 months	Difference in level of triglycerides 6 months after start of treatment.
Metabolic side effects (glucose)	6 months	Difference in level of glucose 6 months after start of treatment.
Endocrine side effects (prolactin)	6 months	Difference in level of prolactin 6 months after start of treatment.
Endocrine side effects (ghrelin)	6 months	Difference in level of ghrelin 6 months after start of treatment.
Metabolic side effects (cholesterol)	6 months	Difference in levels of cholesterol and lipoproteins (LDL, HDL) 6 months after start of treatment.
Extrapyramidal symptoms (EPS)	6 months	Difference in extrapyramidal symptoms measured by Abnormal Involuntary Movement Scale 6 months after start of treatment.
Endocrine side effects (leptin)	6 months	Difference in level of leptin 6 months after start of treatment.
Effectivity (ABC)	6 months	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.
Effectivity (CGI)	6 months	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.
Quality of Life (PedsQL)	6 months	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.
Side effects (blood pressure)	6 months	Difference in diastolic and systolic blood pressure 6 months after start of treatment.

Trial Locations

Locations (1)

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands