To assess microglial activation in first episode patients with psychotic symptoms and first episode medication naïve patients with psychotic symptoms compared to healthy controls using the positron emission tomography (PET) tracer [11C]-R-PK11195.
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the difference in [11C]-R-PK11195 binding potential
(BPND) in various brain regions between subjects with psychosis and healthy
controls.
Secondary outcome
The secondary outcome is the relation between microglial activation and other
markers for neuronal damage and inflammation. This includes grey matter loss,
white matter damage and loss of functional connectivity between brain regions,
as well as inflammatory cytokine concentrations in serum.
Background summary
The pathophysiology of schizophrenia and psychosis is currently unclear.
Growing evidence indicates that neurodegeneration and neuroinflammation is
present in patients with schizophrenia. Microglia activation can be used as an
indirect marker to assess neuronal degeneration and inflammation in
schizophrenia. Previous studies found microglial activation in total gray
matter in schizophrenia patients.
Study objective
To assess microglial activation in first episode patients with psychotic
symptoms and first episode medication naïve patients with psychotic symptoms
compared to healthy controls using the positron emission tomography (PET)
tracer [11C]-R-PK11195.
Study design
This is an open study. All subjects will receive a dose of max. 370 MBq
[11C]-R-PK11195.
Study burden and risks
In total there will be three sessions: a screening session, a visit to the
Department of Nuclear Medicine & PET research of the VU Medical Center (VUmc),
and a magnetic resonance imaging (MRI) scan in the University Medical Center
Utrecht (UMCU). During the screening session questionnaires has to be filled in
and interviews will be held, such as the Comprehensive Assessment of Symptoms
and History (CASH), and standard laboratory tests (2 blood samples, max. 5 ml
each; urine drug test) are performed. During the second visit a magnetic
resonance imaging (MRI) scan will be acquired. Minimal risks are associated
with MRI acquisition.
At the third visit a positron emission tomography (PET) scan will be acquired.
The risks associated with PET scanning are limited, but the subjects will
receive tracer doses of radiation, which is estimated at max. 1.9 milli-Sievert
(mSv). Before PET tracer administration a small sample of blood (max. 5 ml)
will be withdrawn to assess the immunologic concentrations in serum. No
immediate benefits are to be expected from participation in this study for the
subjects. However, an indirect effect in the future is plausible for subjects
with schizophrenia and psychosis, since more knowledge about schizophrenia may
lead to early detection of the disease or improvement in therapy.
Hugo de Grootstraat 9
Utrecht 3581 XR
NL
Hugo de Grootstraat 9
Utrecht 3581 XR
NL
Listed location countries
Age
Inclusion criteria
-Men and women
-Mini Mental State score >27
-Written informed consent of the subject;Specific for patients with psychotic symptoms:
- Presence of schizophrenic and psychotic symptoms according to DSM-IV criteria using the Comprehensive Assessment of Symptoms and History interview (CASH) (N.B. Official DSM-IV diagnosis can be performed six months after onset of symptoms.)
Exclusion criteria
Healthy controls:
-History of psychiatric or neurological illness based (DSM-IV criteria)
-First-degree relatives with a family history of schizophrenia or schizophrenia spectrum disorders
-Any neurological disorder
-(History of) Alcohol and/or drug abuse (DSM-IV criteria)
-Any clinical significant abnormality of any clinical laboratory test, including drug screening (but positive cannabis test is allowed for patients)
-Any condition that may interfere with MRI scanning, e.g. metal objects in or around the body or claustrophobia
-Pregnancy;Specific for medicated patients with psychotic symptoms:
- Any neurological disorder;Specific for first episode medication-naive patients with psychotic symptoms:
- Use of antipsychotics
- Treating physician does not support a delay of medication for the patient (from a clinical perspective)
- Risk that the patient causes serious harm to oneself or others
- Clinical Global Impressions Severity (CGI-S) score 5 or higher
- Psychotic symptoms are too severe to participate (based on CGI-S score and clinical view of treating physician)
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 | NL34092.041.10 |