The objective of the current study is to obtain normative data of healthy individuals on brain measures, cognition and blood markers. In addition, we acquire information on childhood trauma, metabolic and immunological parameters in a cohort of…
ID
Source
Brief title
Condition
- Immune disorders NEC
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We will measure: 1) grey matter brain volumes as measured with Magnetic
Resonance Imaging (MRI); 2) cognitive performance as measured by the Brief
Assessment of Cognition in Schizophrenia (BACS). 3) various immunological
parameters in serum and peripheral blood mononuclear cells. We will measure
normal variation at one timepoint in the above parameters, and compare both
timepoints (baseline and follow-up) to establish what can be considered a
normal range of change over a one year interval in the above parameters.
Secondary outcome
Secondary study parameter/endpoints are; 1) to explain part of the variability
within healthy controls in brain volume and cognitive functioning (as measured
by the Brief Assessment of Cognition in Schizophrenia (BACS)) by estimating the
contribution of various immunological and metabolic parameters as assessed in
blood samples. And 2) the presence and severity of metabolic syndrome as
defined by the American Heart Association/National Heart, Lung and Blood
Institute (AHA/NHLB; Grundy et al., 2005). Also, the experience of childhood
trauma will be assessed using the Childhood Trauma Questionnaire-Short Form
(CTQ-SF). Both may also explain part of the normal variance in brain volume
and cognitive functioning.
Background summary
Schizophrenia research is one of the main focusses of the Psychiatry Department
in the University Medical Center Utrecht. Cognitive deficits and brain volume
loss have been recognized as key features of schizophrenia (Lieberman et al.,
2001; van Haren et al., 2008; Dickerson et al., 2011), as well as altered blood
markers (Mitchell et al., 2011; Dickerson et al., 2013). Interpretation of
findings from these studies is greatly facilitated when a comparison can be
made with healthy individuals. However, few studies have focused on what
biological measures explain (part of the) normal variability in brain volume
and cognition in a sample of healthy controls.
Study objective
The objective of the current study is to obtain normative data of healthy
individuals on brain measures, cognition and blood markers. In addition, we
acquire information on childhood trauma, metabolic and immunological parameters
in a cohort of healthy subjects. This will serve three goals; 1) establish
cross-sectional normative data on brain measures and cognitive functioning at
two timepoints (baseline and follow-up). We will compare normative data of one
timepoint (either baseline or follow-up) with ongoing and future patient
studies at the Psychiatry Department of the University Medical Center Utrecht.
2) establish longitudinal normative change data over the course of a one year
interval. By comparing baseline to follow-up (12 month) measurements, we will
assess changes in brain measures and cognitive functioning. Normative change
data will serve as a reference for ongoing and future patient studies using for
example interventions (i.e. in which change over time is a main endpoint). This
could guide interpretation on what be regarded as deviating in patient
populations. Furthermore, 3) it can be investigated whether (part of) the
variance in one parameter can be explained by variation in the other
parameters. This will be investigated within the healthy cohort of this study.
Specifically, we will compare MRI parameters, cognitive functioning,
immunological and metabolic blood parameters. The secondary endpoints are
assessment of childhood trauma and metabolic syndrome.
Study design
We examine the above-mentioned parameters in healthy individuals at baseline
and after an interval of one year in order to establish normative data on
baseline, follow-up and change in these measures over one year.
Study burden and risks
Participation in the study will entail two measurement with a one-year
interval. The visits will require time investment for the MRI scan (40
minutes), a few physical examinations, questionnaires and two cognitive testing
sessions (around 2.5 hours per visit). The MRI scan is not associated with any
known risks. Blood will be drawn at two occasions with negligible and known
risks (e.g. irritation). The burden and risks are acceptable while the benefits
are expected to be considerable.
Heidelberglaan 100
Utrecht 3508 GA
NL
Heidelberglaan 100
Utrecht 3508 GA
NL
Listed location countries
Age
Inclusion criteria
1) Age between 18 and 70 years
2) Written informed consent is obtained
3) Female subjects with child-bearing potential need to utilize a proper method of contraception (the pill, vaginal ring, hormonal patch, intrauterine device, cervical cape, condom, contraceptive injection, diaphragm) in case of sexual during the study
Exclusion criteria
1) MRI contra-indications, e.g.
i. Ferrous objects in or around the body (e.g. braces, glasses, pacemaker, metal fragments)
ii. Claustrophobia
2) Family history with psychiatric illness (i.e. participants themselves, parents, brothers or sisters of the participant
3) Chronic use of glucocorticosteroids (temporary use is permitted, if stopped at least 1 month before start of the study)
4) Chronic use of non-steroidal anti-inflammatory drugs
5) Current use of statins or other lipid-lowering drugs
6) Pregnancy or breast-feeding (urine pregnancy test will be performed for sexually active females with child bearing potential)
7) Presence of diabetes mellitus, severe heart failure, severe osteoporosis or systemic fungal infections as reported by the participant
8) Concurrent use of certain types of medication:
i. liver enzyme inducing medication such as carbamazepine, riphampicine, primidone,
barbiturates and phenytoine
ii. HAART (both HIV protease inhibitors and (non)-nucleoside reverse transcriptase
inhibitors), especially efavirenz, ritonavir and lopinavir.
iii. telaprevir and boceprevir in treatment of Hepatitis C
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 | NL50657.041.14 |