Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT (SPACe2:STAR)

Erasmus University

Status and phase: Enrolling; Phase 4

Conditions: Autism Spectrum Disorder

Treatments: Other: Therapeutic Drug Monitoring; Other: Risperidone plasma level

Study type: Interventional

Funder types: Other

Identifiers

NCT05146245

2020-005450-18 (EudraCT Number)

MEC-2021-0278

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Therapeutic Drug Monitoring

Experimental group

Description:

Physicians receive dosing advice based on measured blood levels of risperidone and 9-OH-risperidone.

Treatment:

Other: Risperidone plasma level

Other: Therapeutic Drug Monitoring

Care As Usual

Active Comparator group

Description:

Physician decides on possible dosing changes without receiving advice based on blood levels.

Treatment:

Other: Risperidone plasma level