Double-blinded placebo-controlled study of modafinil to relieve the post-exertional exacerbation of fatigue in patients with chronic fatigue syndrome undertaking exercise.

niversity of New South Wales0 个研究点目标入组 20 人开始时间: 2016年4月13日最近更新: 2020年1月13日

适应症

试验速览

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•i) meeting international diagnostic criteria for chronic fatigue syndrome (Fukuda, 1994)
•ii) have their treating exercise physiologist and clinical psychologist resolve that they have a stable pattern of symptom severity, as well as having optimized and stable sleep patterns and well-managed mood disturbance
•iii) undertaking regular of 10-20 minutes walking at a gentle pace without producing a post-exertional exacerbation of symptoms (that is an hour or more of worsened fatigue and other symptoms).

•i) currently use beta-blockers or other agents known to affect heart rate response to exercise; or
•ii) have any medical (e.g. lower limb injury) condition which may preclude reliable participation in exercise testing
•iii) currently use central nervous system medications (e.g. Benzodiazepines and other sedative-hyponotics (e.g. stilnox), anti-epileptics, high-dose antidepressants (low-dose allowed),
•iv) are pregnant or breastfeeding
•v) have hepatic impairment
•vi) are hypersensitive to modafinil
•vii) have a history of left ventricular hypertrophy or ischaemic heart disease, or other clinically significant cardiac disease;
•viii) uncontrolled anxiety disorder,
•ix) have previously taken modafinil and experienced an adverse reaction.
•x) taking anti-hypertensives/beta blockers
•xi) taking corticosteroids
•xii) taking major analgesics (e.g. oxycodone)

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