Safety and pharmacokinetics of antipsychotics in children with autism

Completed

• Conditions: autism; 10034726; behavioral disturbances

• Registration Number: NL-OMON47545
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

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
-Treated with either aripiprazole, risperidone or pipamperone

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 another antipsychotic within the last 6 months
- Known Long QT syndrome (LQTS)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>First, a pharmacokinetic (PK) model is built, linking dosage to drug plasma<br /><br>levels.<br /><br>Second, in the pharmacodynamic (PD) analysis we will investigate the relation<br /><br>between the pharmacokinetic model and weight change.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>In a second pharmacodynamic (PD) analysis we will investigate the relation<br /><br>between the pharmacokinetic model and cardiac<br /><br>changes, extrapyramidal symptoms, metabolic abnormalities, somnolence and<br /><br>clinical effectiveness.<br /><br>We will also verify the relationship between DBS and venipuncture measurements<br /><br>of drug plasma levels in a small subgroup of children. </p><br>