The primary objective is to determine the metabolic rate of [18F]-FHBG in the brain of healthy volunteers, for comparison with the metabolic rate that was found in schizophrenic patients in the previous study.
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 the metabolic rate of [18F]-FHBG in the brain.
Secondary outcome
Secondary study parameters are the results of the PANSS, 15-word test, CPT and
the antibodies against herpes viruses.
Background summary
In a previous pilot study on the role of herpes viruses in schizophrenia it was
found that severely affected schizophrenic patients (based on severity of
psychosis and memory disorder), had a significantly higher metabolic rate of
the PET tracer [18F]-FHBG in the temporal lobe, when compared to mildly
affected patients. The higher metabolic rate of [18F]-FHBG suggests the
presence of active herpes viruses. In order to draw the right conclusion on the
presence of active herpes viruses in the temporal lobe of schizophrenic
patients, it is of importance to compare the metabolic rate of [18F]-FHBG in
patients, to the metabolic rate in healthy volunteers.
Study objective
The primary objective is to determine the metabolic rate of [18F]-FHBG in the
brain of healthy volunteers, for comparison with the metabolic rate that was
found in schizophrenic patients in the previous study.
Study design
This study in healthy volunteers is a pilot study that will performed in
addition to the previous pilot study in schizophrenic patients that was started
in 2005. The study design in the present study will be equal to the study
design in the previous study, to allow for comparison between the healthy
volunteers and the schizophrenic patients.
Healthy volunteers will be recruited via advertisement in public buildings and
local newspapers. Interested healthy volunteers will receive both oral and
written information about the study and will have two weeks time for reflection
to decide whether or not to participate in the study. Healthy volunteers that
would like to participate in the study are asked to sign the written informed
consent. To determine whether the inclusion and exclusion criteria are met, the
healthy volunteer has to fill in a questionnaire. When the healthy volunteer
meets the inclusion and exclusion criteria, he/she is scheduled for the
PANSS-interview, and the attention and memory tests. Within two weeks after the
PANSS-interview and the tests, the [18F]-FHBG PET scan will be performed. Prior
to the PET scan, blood will be collected for determination of antibodies
against herpes viruses.
Study burden and risks
The healthy volunteers are exposed to radioactivity with minor to moderate
risk, according to the International Commission on Radiological Protection
(ICRP62). Healthy volunteers do not benefit from the study, but their
participation may lead towards a better understanding on the role of herpes
viruses in schizophrenia (i.e. the etiology of schizophrenia) and may lead
towards improved treatment strategies.
Hanzeplein 1
9700 RB Groningen
NL
Hanzeplein 1
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
-Age above 18
-Written informed consent for participation
Exclusion criteria
-Pregnancy, or presumption of pregnancy
-The use of anticoagulants or having coagulation disorder
-Use of any investigational drug
-Use of somatic medication which may affect the immune system
-Current or recent (<1 year) alcohol or substance abuse
-Current psychiatric disorder or a first degree family member with a major psychiatric disorder
-Current systemic disease
-Current infection with a herpes virus
-Major metabolic disease
-Somatic, organic or neurological disorder
-Participation in a scientific research study (<1 year) involving radiation
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 | NL37503.042.11 |