NCT05146245
Recruiting
Phase 4
Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT
ConditionsAutism Spectrum Disorder
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Autism Spectrum Disorder
- Sponsor
- Erasmus Medical Center
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- BMI z-score
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Birgit Koch
Prof.Dr.
Erasmus Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
BMI z-score
Time Frame: 6 months
Difference in body mass index z-scores 6 months after start of treatment.
Secondary Outcomes
- Metabolic side effects (triglycerides)(6 months)
- Metabolic side effects (glucose)(6 months)
- Endocrine side effects (prolactin)(6 months)
- Endocrine side effects (ghrelin)(6 months)
- Metabolic side effects (cholesterol)(6 months)
- Extrapyramidal symptoms (EPS)(6 months)
- Endocrine side effects (leptin)(6 months)
- Effectivity (ABC)(6 months)
- Effectivity (CGI)(6 months)
- Quality of Life (PedsQL)(6 months)
- Side effects (blood pressure)(6 months)
Study Sites (1)
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