The aim of the proposed study is to investigate the presence of dopaminergic abnormalities, as measured with [11C]raclopride, in relation to antipsychotic medication discontinuation in patients remitted after a first-episode psychosis (FEP).…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is be the binding potential of [11C]raclopride in the
striatum (caudate and putamen).
Secondary outcome
n.a.
Background summary
Discontinuation of antipsychotic medication after use of these drugs for
several months may render patients especially vulnerable to relapse. Potential
mechanism behind this vulnerability could be increased density of postsynaptic
dopamine D2 receptors in the striatum. This mechanism has been demonstrated in
rats and mice, but never in first episode psychosis (FEP) patients.
Study objective
The aim of the proposed study is to investigate the presence of dopaminergic
abnormalities, as measured with [11C]raclopride, in relation to antipsychotic
medication discontinuation in patients remitted after a first-episode psychosis
(FEP). Secondary objectives are to compare baseline levels of [11C]raclopride
between FEP patients in remission who have discontinued antipsychotic
medication with ultra-high risk (UHR) individuals who are antipsychotic-naïve
and healthy individuals who are antipsychotic-naïve.
Study design
The proposed study has an observational design. For this study, subjects will
be scanned in a PET-scanner under resting conditions.
Study burden and risks
The subjects of this study will undergo a [11C]raclopride PET scan. Healthy
control subjects will undergo the PET scan once. The FEP patients will undergo
two PET scans, one 1-7 days after discontinuation of antipsychotic medicine and
one after 6-8 weeks after discontinuation. Participation in the study will
entail a session that will involve a PET scan of approximately 60 minutes. The
only adverse event can be a bruise as a result of the arterial catheter. In
addition, according to ICRP62 the radiation level of 2.8 mSv is within the
category IIb, minor to moderate risk (1-10 mSv). For anatomical reference,
which is lacking in PET, an MRI scan of the subjects is needed. For all
subjects, an MRI scan will be made in addition to the PET scan. The MRI scan
will last 60 minutes, and will pose no risk. The risks associated with
participation and the benefits to the individuals are negligible. The potential
benefit to society in the future is considerable if the findings lead to more
insight in antipsychotic induced psychosis.
Ant. Deusinglaan 2
Groningen 9736 AW
NL
Ant. Deusinglaan 2
Groningen 9736 AW
NL
Listed location countries
Age
Inclusion criteria
* The participant understands the study and is able to provide written informed
consent
* Must be between the ages of 18-60
* Sufficient command of the Dutch language
* Must have a diagnosis of schizophrenia, schizoaffective disorder,
schizophreniform disorder, or those classified as Other Specified Schizophrenia
Spectrum and Other Psychotic Disorder
* Be mentally competent, as determined by their treating physician
* The participant has had a first episode of psychosis and uses antipsychotic
medication at the start of the HAMLETT study
* The participant is about to discontinue antipsychotic medication
* Psychotic symptoms are in remission for 3-6 months
* HAMLETT is the only medical-scientific medication study in which the patient
participates
Exclusion criteria
* Presence of a neurological disorder
* Visual or hearing problems that cannot be corrected
* Participation in a scientific research study during the past year involving
radiation
* the refusal to be informed (by notifying the participant*s physician) of
structural brain abnormalities that could be detected during the experiment
* MR incompatible implants in the body
* Risk of having metal particles in the eyes
* Tattoo*s containing red pigments that form a safety risk
* Alcohol or substance abuse in the past 6 months
* Insufficient knowledge of the Dutch language
* Inability to undergo cognitive testing
* Use of antipsychotic medication
* dangerous or harmful behaviour (i.e. behaviour with a risk of severe physical
injury, or actual physical injury inflicted, to self or others) occurred during
the psychosis
* Coercive treatment (based on a judicial ruling)
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 | NL64040.042.17 |