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Study aim
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Studying the effectiveness of lisdexamfetamine dimesylate in relieving fatigue in patients with MS.
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Design
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To randomly assign the samples to two groups of 25, the block method will be used. The sampling method will be available sampling.
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Settings and conduct
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The study is being conducted at the MS Clinic of the Bu Ali Sina Medical Center in Sari. Patients will initially receive lisdexamfetamine at a dose of 30 mg daily, and then, if tolerated, will be increased by 20 mg every 2 weeks to a maximum dose of 70 mg, and then continue for 4 weeks. The drug and placebo will be placed in identical, identical drug packages from Tekajeh Company, which are coded based on a randomized table. Each code will be assigned to a specific patient.
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Participants/Inclusion and exclusion criteria
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The inclusion criteria : adults over 18 years old with multiple sclerosis according to the McDonald 2017 criteria and EDSS less than 5.5 and according to the Fatigue MIFS>33 criteria; individuals had informed consent to enter the study.
The exclusion criteria: severe depression; hypothyroidism; severe anemia (Hb‹ 9 g/dl); breastfeeding or pregnancy; history of ischemic cva or cardiovascular disease; decreased renal function; presence of an MS attack within the past month; uncontrolled blood pressure (BP ≥ 160/100 mm Hg); concomitant use of medications that affect fatigue; history of drug, psychotropic, and alcohol abuse; concomitant use of MAOI and SSRI; presence of narcolepsy; presence of psychosis; history of seizures; history of vascular disorders
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Intervention groups
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Patients were given lisdexamfetamine at doses of 30, 50, 70, and placebo, and the effect on fatigue was examined.
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Main outcome variables
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the improvement in their fatigue and quality of life was assessed and recorded based on the Kurtzke Functional Systems Scores (MSFC, FSS), PSQI, MFI, SF-36, Fatigue Severity Scale (FSS) of Sleep Disorders, and HADS.