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This study compares Anakinra with a placebo in women with chronic fatigue syndrome to see whether blocking a cytokine (an immune signaling molecule) reduces fatigue. Women aged 18-59 with a CDC-based diagnosis of chronic fatigue syndrome and marked functional impairment were able to take part. The study was carried out in Phase 2/Phase 3 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * CDC-diagnosed CFS-patients; * female, between 18 and 59 years old; * fatigue duration ≤10 years, or significant increase of complaints during the last 10 years * 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 ≥700. Exclusion Criteria: * pregnant or nursing women; * women who intend to get pregnant during the study; * fatigue duration \>10 years; * 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 (major depression, psychosis, eating disorders, anxiety disorders, bipolar disease and post traumatic stress disorder) assessed with the MINI; * live vaccination during the past four weeks; * current engagement in a legal procedure with respect to disability claims.