Chronic Fatigue Syndrome
Conditions
Interventions
Product Name: [11C]PK11195
Product Code: [11C]PK11195
Pharmaceutical Form: Injection
INN or Proposed INN: [11C]PK11195
CAS Number: n/a
Current Sponsor code: [11C]PK11195
Other descriptive name: [11C]P
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): n/a;Timepoint(s) of evaluation of this end point: n/a | — |
Countries
Netherlands
Contacts
Public ContactClinical Trial Information
University Medical Center Groningen
Outcome results
None listed