Inhibition of the immune system in patients with the Chronic Fatigue syndrome.
- Conditions
- Chronic Fatigue SyndromeTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2013-005466-19-NL
- Lead Sponsor
- RadboudUMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
In order to be eligible to participate in this study, a subject must meet
all of the following criteria:
• CDC-diagnosed CFS-patients;
• female, between 18 and 59 years old;
• score of >40 on 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 > 800.
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 46
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
A potential subject who meets any of the following criteria will be
excluded from participation in this study:
• pregnant or nursing women;
• women who intend to get pregnant during the study;
• patients who use or have used psychotropic medication in the past
month;
• substance abuse in the past 3 months;
• patients taking any medication except oral contraceptives and/or
paracetamol;
• patients with evident somatic co-morbidity;
• previous or current engagement in CFS research;
• inability to understand the nature and the extent of the trial and the
procedure required;
• psychiatric co-morbidity assessed with the MINI;
• any condition, which in the opinion of the investigators might
interfere with the evaluation of the study objects;
• current engagement in a legal procedure.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method