Investigating normal variability in brain volumes and cognition in a healthy population.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>We will measure: 1) grey matter brain volumes as measured with Magnetic<br /><br>Resonance Imaging (MRI); 2) cognitive performance as measured by the Brief<br /><br>Assessment of Cognition in Schizophrenia (BACS). 3) various immunological<br /><br>parameters in serum and peripheral blood mononuclear cells. We will measure<br /><br>normal variation at one timepoint in the above parameters, and compare both<br /><br>timepoints (baseline and follow-up) to establish what can be considered a<br /><br>normal range of change over a one year interval in the above parameters. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameter/endpoints are; 1) to explain part of the variability<br /><br>within healthy controls in brain volume and cognitive functioning (as measured<br /><br>by the Brief Assessment of Cognition in Schizophrenia (BACS)) by estimating the<br /><br>contribution of various immunological and metabolic parameters as assessed in<br /><br>blood samples. And 2) the presence and severity of metabolic syndrome as<br /><br>defined by the American Heart Association/National Heart, Lung and Blood<br /><br>Institute (AHA/NHLB; Grundy et al., 2005). Also, the experience of childhood<br /><br>trauma will be assessed using the Childhood Trauma Questionnaire-Short Form<br /><br>(CTQ-SF). Both may also explain part of the normal variance in brain volume<br /><br>and cognitive functioning.</p><br>