Brain inflammation in patients with chronic fatigue syndrome

Conditions: Chronic Fatigue Syndrome
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2014-004448-37-NL

Lead Sponsor: niversity Medical Center Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

Control subjects
> Female, between 18 and 55 years old;
> Neighbourhood control

CFS patients
> CDC-diagnosed CFS-patients;
> Female, between 18 and 55 years old;
> Score of =40on the subscale fatigue severity of the CIS (Checklist Individual Strength);
> Marked functional impairment assessed with the Sickness Impact Profile (SIP-8) and operationalised as a total score of =700.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

All subjects
> Women who are pregnant;
> Women who intend to get pregnant during the study;
> Use or having used psychotropic medication in the past six months;
> Alcohol or substance abuse in the past 3 months;
> Taking any medication, except oral contraceptives;
> Evident somatic/psychiatric co-morbidity;
> Participation in a scientific research study during the past year involving radiation.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to evaluate whether there is an increased binding potential of the TSPO ligand [11C]PK11195, which is a marker for microglia activation in neuroinflammation, using PET in patients with CFS compared to healthy neighbourhood controls.;Secondary Objective: Secondary objective(s) are to correlate the binding potential of [11C]PK11195 to (1) MRI measurements in the same subjects, (2) to fatigue severity using the CIS fatigue questionnaire and (3) to peripheral cytokine concentrations.;Primary end point(s): n/a;Timepoint(s) of evaluation of this end point: n/a

Secondary Outcome Measures