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Safety and pharmacokinetics of antipsychotics in children with autism


- candidate number24741
- NTR NumberNTR6050
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-aug-2016
- Secondary IDsNL56247.078.16 MEC-2016-124
- Public TitleSafety and pharmacokinetics of antipsychotics in children with autism
- Scientific TitleSafety and pharmacokinetics of antipsychotics in children with autism
- ACRONYMSPACe
- hypothesisThe occurrence of clinical side effects in children using aripiprazole, risperidone or pipamperone can be modeled using drug plasma levels.
- Healt Condition(s) or Problem(s) studiedAutism Spectrum Disorders (ASDs)
- 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)
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jun-2016
- planned closingdate1-jan-2019
- Target number of participants90
- InterventionsNone
- Primary outcomeFirst, 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 outcomeIn 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.
- TimepointsStart, 4 weeks, 12 weeks, 24 weeks
- Trial web sitefollows
- statusplanned
- CONTACT FOR PUBLIC QUERIES SM Kloosterboer
- CONTACT for SCIENTIFIC QUERIESDr. B.C.P. Koch
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryOur 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.
- Main changes (audit trail)
- RECORD5-aug-2016 - 3-nov-2016


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