No registrations found.
ID
Source
Brief title
Health condition
Autism Spectrum Disorder (autisme spectrum stoornis)
Sponsors and support
Intervention
Outcome measures
Primary outcome
First, a pharmacokinetic (PK) model is built, linking dosage to drug plasma levels.
Second, in the pharmacodynamic (PD) analysis we will investigate the relation between the pharmacokinetic model and weight change.
Secondary outcome
In a second pharmacodynamic (PD) analysis we will investigate the relation between the pharmacokinetic model and cardiac
changes, extrapyramidal symptoms, metabolic abnormalities, somnolence and clinical effectiveness.
We will also verify the relationship between DBS and venipuncture measurements of drug plasma levels in a small subgroup of children.
Background summary
Our main objective is to develop a pharmacokinetic safety window in children and adolescents for the three most prescribed antipsychotics in the Netherlands, risperidone, pipamperon and aripiprazole. To this end we will study the relation of the measured pharmacokinetic parameters with weight change and extrapyramidal side effects over a 6 month period using a minimally invasive Dry Blood Spot technique (DBS).
As a secondary objective, we will investigate the relation between the plasma levels of the antipsychotics and cardiac changes, metabolic abnormalities, somnolence and clinical effectiveness. We will conduct a multicentre, prospective, observational cohort study. No study intervention will occur. We will include 30 patients in each treatment group which will be followed for 6 months.
Study objective
The occurrence of clinical side effects in children using aripiprazole, risperidone or pipamperone can be modeled using drug plasma levels.
Study design
Start, 4 weeks, 12 weeks, 24 weeks
Intervention
None
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 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 antipsychotic medication within the last 6 months
- Known Long QT syndrome (LQTS)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5879 |
| NTR-old | NTR6050 |
| CCMO | NL56247.078.16 |
| OMON | NL-OMON47545 |