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Clinical validation of the Dry Blood Spot (DBS) method for risperidone, aripiprazole, pipamperone and its major metabolites


- candidate number27800
- NTR NumberNTR6655
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-aug-2017
- Secondary IDsMEC-2016-123 / NL57233.078.16  METC van het Erasmus MC / toetsingonline (CCMO)
- Public TitleClinical validation of the Dry Blood Spot (DBS) method for risperidone, aripiprazole, pipamperone and its major metabolites
- Scientific TitleClinical validation of the Dry Blood Spot (DBS) method for risperidone, aripiprazole, pipamperone and its major metabolites
- ACRONYMDAPpeR
- hypothesisDried Blood Spot is a reliable method to determine antipsychotic blood levels.
- Healt Condition(s) or Problem(s) studiedAntipsychotics, Dried blood spot (DBS) testing
- Inclusion criteria- using either aripiprazole, risperidone, paliperidone or pipamperone
- ≥ 18 years
- Exclusion criterianone
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 9-jun-2016
- planned closingdate31-dec-2017
- Target number of participants60
- InterventionsParticipants will undergo one fingerprick and venipuncture which will cause mild local irritation.
- Primary outcomeThe main study parameter is the agreement between antipsychotic drug plasma levels of blood collected by venipuncture or DBS, both measured by ultra-performance liquid chromatography tandem mass-spectrometry (UHPLC-MS/MS)
- Secondary outcomeCovariates influencing through levels
- Timepointsonly one measurement
- Trial web sitenot applicable
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. B.C.P. Koch
- CONTACT for SCIENTIFIC QUERIESDr. B.C.P. Koch
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZonMw
- Publicationsnone
- Brief summaryThe advantages in of the new Dry Blood Spot (DBS) method have been recognized for use in TDM. DBS allows drug monitoring in a home setting with a single fingerprick, which is less invasive, painful and stressful. A DBS method for determination of the mostly prescribed antipsychotics risperidone, pipamperone and aripiprazole has been developed. The objective of this study is to clinically validate this method. 20 patients per drug will undergo a DBS fingerprick and venipuncture simultaneously. The two measurements will be compared using Deming regression and Bland Altmand plots.
- Main changes (audit trail)
- RECORD29-aug-2017 - 1-sep-2017


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