the clinical validation of the DBS method for determination of risperidone, pipamperon and aripiprazole and their metabolites.
ID
Source
Brief title
Condition
- Disturbances in thinking and perception
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
the 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 outcome
Covariates influencing through levels
Background summary
Antipsychotic drugs play an important role in the treatment of comorbid
behavioural problems in children with autism spectrum disorders (ASD).
Unfortunately, treatment with anti-psychotics is associated with a number of
serious side effects, like cardiac, metabolic and extrapyramidal abnormalities.
Therapeutic Drug Monitoring (TDM) could help to achieve the best therapeutic
results with the lower risk of toxicity and side effects. The advan¬tages 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
Study objective
the clinical validation of the DBS method for determination of risperidone,
pipamperon and aripiprazole and their metabolites.
Study design
cross-sectional intervention study
Study burden and risks
Participants will undergo one fingerprick, which will cause mild local
irritation. Possibly an extra blood sample will be taken during regular,
scheduled venipuncture, which will cause no extra inconvenience. If no
venipuncture was planned, a venipuncture will be done which might cause mild
local pain. The procedures only take 10 minutes.
Once validated DBS can be of great benefit to an extended population, as
antipsychotics are commonly prescribed in the Netherlands. The associated risks
of the use of this medication could be minimalized in a minimally invasive
order in the home setting.
In order to reach the target study sample, also mentally disabled/incompetent
persons will be included, as pipamperone is preferably and almost exclusively
prescribed to this patient group.
's Gravendijkwal 230
Rotterdam 3000 CA
NL
's Gravendijkwal 230
Rotterdam 3000 CA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- using either aripiprazole, risperidone, paliperidone or pipamperone
- 18 years or older
Exclusion criteria
nvt
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57233.078.16 |