Objectives: Primary objective: - To investigate whether high-resolution glutamate levels in the brain of patients that experienced a psychosis differ from healthy individuals.Secondary objectives:- To compare the high resolution glutamate…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameter:
- High-resolution brain glutamate levels.
Secondary outcome
Secondary study parameters:
- Symptom severity in patients who experienced a psychosis
o Short cognitive test battery
o Positive and negative symptoms (Positive and Negative Symptoms Scale (PANNS))
o Functional impairment (using the Manchester Short Assessment of Quality of
Life)
- Structural (brain volumes) and functional (resting state BOLD signal) brain
parameters.
- (epi)Genetic variation in glutamatergic genes.
Background summary
Rationale: An increasing number of studies point to a role for glutamatergic
dysfunction in the pathophysiology of psychosis. In vivo glutamate levels can
be non-invasively measured with proton magnetic resonance spectroscopy
(1H-MRS). A major methodological drawback is the fact that glutamate levels are
currently measured in one rather large preselected voxel (usually around 8
cm3). This sharply contrasts with the ubiquitous presence of glutamate across
the brain and the convincing evidence for altered glutamate functionality in
psychotic disorders in cortical, limbic, and striatal regions. This study uses
a novel spectroscopy approach to investigate high-resolution in vivo glutamate
levels across the brain in psychosis using a multichannel crusher coil.
Therefore, we can now investigate how glutamatergic dysfunction in after an
episode of psychosis affects glutamate levels across the brain at high
resolution, including the possibility to map interlinked regions.
Study objective
Objectives:
Primary objective:
- To investigate whether high-resolution glutamate levels in the brain of
patients that experienced a psychosis differ from healthy individuals.
Secondary objectives:
- To compare the high resolution glutamate distributions to
o symptom severity in first episode psychosis patients (cognitive and psychotic
symptoms, as well as functional impairment)
o structural (brain volumes) and functional (resting state BOLD signal) brain
parameters of all participants.
- To investigate whether (epi)genetic variation in glutamatergic genes affects
glutamate levels in both patients and healthy controls.
Study design
Study design:
A small monocenter study in patients who experienced a psychosis (N=50) and
healthy individuals (N=50). Participants will undergo one scanning session in
the 7T scanner (duration around 60 min) and complete a cognitive test battery.
Study burden and risks
Risks for participants are minimal. Participation consists of some
questionnaires taking approximately half an hour, and one session with a
duration of approximately 3,5 hours and sufficient time for breaks. No direct
benefits are present for participants. All participants will be given a
reimbursement of ¤40,- for their cooperation and time. Also potential travel
costs will be reimbursed.
The visit includes:
- Inclusion, collection of a blood sample (duration around 60-90 min, depending
on whether PANSS interview is needed)
- Completion of cognitive test battery (duration around 60 min).
- One MRI scan in the 7Tesla scanner (duration around 60 min).
Regarding a risk analysis, a negligible risk for participants is estimated. One
scanning session with a duration of 60 minutes in the 7T scanner has often been
applied without any known disadvantageous effects as reviewed in literature
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
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:;Inclusion criteria for all subjects (patients and healthy controls):
* 16-40 years old.
* Written informed consent of the subject;Patients who experienced a psychosis:
* Psychosis (ICD-10 criteria for any functional psychotic illness: F10-19, excluding coding F1x.0 for Acute intoxication; F20-29 and F30-39, psychotic codings).
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:;General exclusion criteria for all individuals:
- Use of certain drugs and medication
- Any previous neurosurgery or neurological disorder, including epilepsy
- Any contraindications for MRI
- Subjects who do not fully comprehend the purpose or are not competent to make a rational decision whether or not to participate
- Patients who were admitted to a psychiatric unit involuntarily after being given an *inbewaringstelling* (IBS). Patients with *rechterlijke machtigingen* (RM) may be included, but only if they are mentally competent (see section on mental competence and decisional capacity above). The reasons for including these patients are that this will increase the likelihood of attaining the projected number of study participants and that inclusion of these patients will contribute to assembling a study population representative of all Dutch patients. ;Additional exclusion criteria for healthy controls:
- Current Axis-I psychiatric disorder
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 | NL55796.041.15 |