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

Autism Spectrum Disorder Clinical Trial

— SPACe2:STAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05146245
• Other study ID #: MEC-2021-0278
• Secondary ID: 2020-005450-18
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2021
• Est. completion date: May 2024

Study information

• Verified date: December 2023
• Source: Erasmus Medical Center
• Contact: Birgit Koch
• Email: b.koch[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Other:
• Therapeutic Drug Monitoring
Physician receives dosing advice based on risperidone plasma level.
• Risperidone plasma level
Plasma levels of risperidone and 9-OH risperidone are measured in a Dried Blood Spot.

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (3)

Lead Sponsor	Collaborator
Erasmus Medical Center	Stichting de Merel, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI z-score	Difference in body mass index z-scores 6 months after start of treatment.	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Metabolic side effects (glucose)	Difference in level of glucose 6 months after start of treatment.	6 months
Secondary	Metabolic side effects (cholesterol)	Difference in levels of cholesterol and lipoproteins (LDL, HDL) 6 months after start of treatment.	6 months
Secondary	Metabolic side effects (triglycerides)	Difference in level of triglycerides 6 months after start of treatment.	6 months
Secondary	Endocrine side effects (prolactin)	Difference in level of prolactin 6 months after start of treatment.	6 months
Secondary	Extrapyramidal symptoms (EPS)	Difference in extrapyramidal symptoms measured by Abnormal Involuntary Movement Scale 6 months after start of treatment.	6 months
Secondary	Endocrine side effects (ghrelin)	Difference in level of ghrelin 6 months after start of treatment.	6 months
Secondary	Endocrine side effects (leptin)	Difference in level of leptin 6 months after start of treatment.	6 months
Secondary	Side effects (blood pressure)	Difference in diastolic and systolic blood pressure 6 months after start of treatment.	6 months