The occurrence of clinical side effects in children using aripiprazole, risperidone or pipamperone can be modeled using drug plasma levels.
ID
Bron
Verkorte titel
Aandoening
Autism Spectrum Disorder (autisme spectrum stoornis)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
First, a pharmacokinetic (PK) model is built, linking dosage to drug plasma levels.<br>
Second, in the pharmacodynamic (PD) analysis we will investigate the relation between the pharmacokinetic model and weight change.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
The occurrence of clinical side effects in children using aripiprazole, risperidone or pipamperone can be modeled using drug plasma levels.
Onderzoeksopzet
Start, 4 weeks, 12 weeks, 24 weeks
Onderzoeksproduct en/of interventie
None
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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)
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5879 |
| NTR-old | NTR6050 |
| CCMO | NL56247.078.16 |
| OMON | NL-OMON47545 |