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Query: UMLS:C0015672 (fatigue)
 51,768 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Modafinil may be a potentially effective treatment for primary biliary cirrhosis (PBC)-related fatigue. About 42 patients were given a 3-day trial of 100-200 mg modafinil. Response was defined as increased energy, decreased somnolence and sleep requirements, and improved daily function. Patients with positive responses were continued indefinitely on the medication. During the initial trial period, 31 (73%) patients had complete response and continued to take the medication. Eleven (26%) had no response. In long-term follow-up (average 17.7 months), 25 (81%) patients continued to take 100-200 mg modafinil daily. Some required an increased dosage and some took the medication as needed. Four (12%) patients stopped the medication because of side-effects or reduced efficacy; one patient (3%) stopped due to medication cost and one (3%) due to resolution of fatigue. Side-effects included insomnia, nausea, nervousness, and headaches. Modafinil appears to be a safe, effective treatment for PBC-related fatigue.
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PMID:Modafinil in the treatment of debilitating fatigue in primary biliary cirrhosis: a clinical experience. 1908 90

Our objective was to determine whether modafinil alleviates fatigue in patients with amyotrophic lateral sclerosis (ALS). A placebo controlled trial with a 3:1 modafinil:placebo randomization in doses up to 300 mg/day for 4 weeks was followed by 8 weeks of open maintenance treatment. The primary endpoint was the Clinical Global Impressions-Improvement Scale. Secondary endpoints were the Fatigue Severity Scale, Epworth Sleepiness Scale, Beck Depression Inventory, Role Function Scale, and visual analog scales. Analysis of covariance was used to assess change at Week 4. Thirty-two patients were randomized; 29 completed the 4-week trial. In intention to treat (ITT) analysis, the response was 76% for modafinil versus 14% for placebo. In a completer analysis, the modafinil response rate was 86%, and the placebo response rate remained 14%. The number needed to treat was 1.6 (ITT). No medically serious adverse events were reported. Modafinil may be a promising intervention for fatigue in ALS patients. Replication in a larger study is needed.
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PMID:Modafinil treatment of fatigue in patients with ALS: a placebo-controlled study. 1920 4

Cancer-related fatigue is the most prevalent and distressing symptom experienced by patients with advanced cancer. Central nervous system stimulants have been shown to relieve fatigue in nonmalignant disease. Modafinil is a stimulant with a selective site of action in the brain that is better tolerated than traditional stimulants, such as methylphenidate. The aim of this study was to determine the feasibility of conducting a randomised controlled trial to assess the efficacy and safety of modafinil for the treatment of fatigue in patients with lung cancer. Twenty patients with non-small cell lung cancer were recruited to this open-label study. Modafinil was taken in a fixed dose-titration schedule of 100 mg daily for 7 days followed by 200 mg daily for 7 days. Fifteen patients completed the study. During the study period, there was a rapid and statistically significant reduction in the primary outcome, fatigue (P = 0.001) and the secondary outcomes of daytime sleepiness and depression/anxiety. This improvement in fatigue was also clinically significant. Ten patients chose to continue modafinil after the study and the drug was well-tolerated. It would be both feasible and worthwhile to conduct a definitive randomised controlled trial to determine the role of modafinil in the treatment of cancer-related fatigue.
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PMID:Modafinil for the treatment of fatigue in lung cancer: a pilot study. 1927 33

Cognitive impairment seems to be highly prevalent in patients with advanced cancer. Modafinil, a novel vigilance and wake-promoting agent, may be an alternative treatment. We wanted to investigate this treatment on attentional and psychomotor dysfunction in cancer patients. 28 cancer patients with a tiredness score of 50 mm or more on a scale of 0 to 10 (0=no tiredness, 10=worst possible tiredness) and Karnofsky Performance Status 40-70 were included. All medications were kept stable during the trial despite short acting opioids for breakthrough pain. On day 1 the patients were randomly assigned to receive 200 mg Modafinil orally or placebo and on day 4 they crossed-over to the alternative treatment. Finger Tapping Test (FTT), Trail Making Test (TMT) and Edmonton Symptom Assessment System (ESAS) were evaluated before tablet intake and again 4, 5 hours after. FTT for the dominant hand as well as TMT were statistically significantly improved on modafinil (p-values=0.006 and 0.042, respectively). On ESAS, depression and drowsiness also improved statistically significantly (p-values=<0.001 and 0.038, respectively). Modafinil in a single dose regimen was significantly superior to placebo regarding two cognitive tests of psychomotor speed and attention. Furthermore subjective scores of depression and drowsiness were significantly improved by modafinil.
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PMID:Modafinil for attentional and psychomotor dysfunction in advanced cancer: a double-blind, randomised, cross-over trial. 1964 24

Modafinil is a novel wake-promoting agent approved for the treatment of excessive sleepiness associated with narcolepsy that holds significant promise as an alternative treatment to traditional psychostimulants for excessive fatigue associated with medical and psychiatric disorders and as augmentation medication for treatment-resistant depression.
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PMID:Modafinil: past, present and future. 1981 Sep 41

Fatigue is common in Parkinson's disease (PD), occurring in up to 42% of patients (2). There is no recognized treatment. This is a study of modafinil for Parkinson's disease related fatigue. Ethical approval was given. Patients with idiopathic PD were recruited from a Movement Disorders clinic. Those with depression, dementia, and other causes for fatigue were excluded. Patients were assessed using the Fatigue Severity Scale (FSS), Hospital Anxiety and Depression Scale (HADS), self-rating of improvement, Epworth Sleepiness Scale (ESS), and UPDRS. Modafinil was titrated up over 4 weeks to maximum of 400 mg/day. There followed a 5 week maintenance phase before reassessment. Thirteen patients participated. No significant change was seen in any safety measure. The FSS did not change significantly, however those on modafinil rated an improvement in their fatigue compared to placebo. The Modafinil group had a statistically significant improvement on ESS (p < 0.05). This is a small study of modafinil in selected PD patients. There is a suggestion of improvement on the global clinical impression scale for fatigue, but no significant change on FSS. A larger study is needed to further evaluate this drug in PD fatigue. This study highlights the problems with recruitment when trialing treatments of non-motor symptoms in PD. A significant improvement in EDS was seen.
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PMID:Modafinil for Parkinson's disease fatigue. 1984 11

Modafinil differs from other arousal-enhancing agents in chemical structure, neurochemical profile, and behavioral effects. Most functional neuroimaging studies to date examined the effect of modafinil only on information processing underlying executive cognition, but cognitive enhancers in general have been shown to have pronounced effects on emotional behavior, too. We examined the effect of modafinil on neural circuits underlying affective processing and cognitive functions. Healthy volunteers were enrolled in this double-blinded placebo-controlled trial (100 mg/day for 7 days). They underwent BOLD fMRI while performing an emotion information-processing task that activates the amygdala and two prefrontally dependent cognitive tasks-a working memory (WM) task and a variable attentional control (VAC) task. A clinical assessment that included measurement of blood pressure, heart rate, the Hamilton anxiety scale, and the profile of mood state (POMS) questionnaire was also performed on each test day. BOLD fMRI revealed significantly decreased amygdala reactivity to fearful stimuli on modafinil compared with the placebo condition. During executive cognition tasks, a WM task and a VAC task, modafinil reduced BOLD signal in the prefrontal cortex and anterior cingulate. Although not statistically significant, there were trends for reduced anxiety, for decreased fatigue-inertia and increased vigor-activity, as well as decreased anger-hostility on modafinil. Modafinil in low doses has a unique physiologic profile compared with stimulant drugs: it enhances the efficiency of prefrontal cortical cognitive information processing, while dampening reactivity to threatening stimuli in the amygdala, a brain region implicated in anxiety.
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PMID:Modulatory effects of modafinil on neural circuits regulating emotion and cognition. 2055 11

Fatigue is a highly prevalent and distressing symptom associated with significant psychological and functional morbidity and decreased quality of life among patients with cancer. Despite its impact on patients and caregivers, fatigue is underreported and underrecognized, and remains untreated among patients with cancer because of various patient- and clinician-related factors. In addition to assessment for potentially reversible medical causes or medications exacerbating fatigue, and the implementation of nonpharmacologic interventions, several pharmacologic treatment options have been considered for the treatment of cancer-related fatigue. Among traditional psychostimulants, methylphenidate has been studied the most and is effective and well tolerated among patients with cancer despite common side effects. Modafinil, a novel psychostimulant commonly referred to as wakefulness-promoting agents as a group, has also been studied and seems to be well tolerated among patients with cancer. A large placebo effect has been reported in most randomized controlled trials with psychostimulants. Thus, randomized placebo-controlled trials with large sample sizes are needed to further assess the efficacy and tolerability of psychostimulants in the treatment of cancer-related fatigue. This article presents a comprehensive review of the use of psychostimulant agents for fatigue among patients with cancer, including an overview of the clinical trials with psychostimulants and of the clinical guidelines available for treatment of cancer-related fatigue.
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PMID:Psychostimulants for cancer-related fatigue. 2087 Jun 37

Fatigue is prevalent among patients with hepatitis C virus (HCV) and with HIV/AIDS but there are no established fatigue treatments for either condition or their combination. We analysed data from three trials of modafinil or armodafinil for HIV-positive patients with fatigue, including 36 co-infected with HCV, to compare treatment response and safety parameters related to HCV status. One hundred and twenty patients received active drug and 70 were randomized to placebo. Fatigue response rate to modafinil/armodafinil was 100% for patients with HCV (18/18) and 73% (74/102) for patients without HCV. Placebo response rate was 28% (5/18) and 29% (15/52), respectively. Depressive symptoms improved only when energy improved. Viral load declined from baseline after 12 and 26 weeks of active medication. CD4 cell count did not change, nor did alanine transaminase and aspartate aminotransferase for patients with HCV. Patients with haematocrit below the reference range responded, as well as patients whose values were within the reference range. Modafinil and armodafinil appear effective and well tolerated for treating fatigue among both HCV-positive and HCV-negative patients with HIV/AIDS, suggesting that they may hold promise for HIV-positive patients considering alpha interferon/ribavirin treatment for HCV. Further investigation in a focused trial is warranted.
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PMID:Modafinil and armodafinil treatment for fatigue for HIV-positive patients with and without chronic hepatitis C. 2142 31

Fatigue and excessive daytime sleepiness are common symptoms in patients with neurological injury. Modafinil has been shown to ameliorate these symptoms, but its use in patients with seizures has been limited because of safety concerns. Using a large centralized clinical registry, we performed a retrospective chart review of patients with a diagnosis of epilepsy who were given modafinil over a 10-year period. A total of 205 patients were analyzed. There were 91 patients who had seizures while taking modafinil; there was no relationship between modafinil dosage and whether the patient had seizures. There were 6 patients in whom modafinil was discontinued because of concern for seizure exacerbation, and 4 patients had de novo seizures after starting modafinil. In 29 patients with epilepsy only, no major seizure exacerbation was seen. Modafinil is potentially safe in patients with epilepsy, but further prospective studies are needed to fully determine its safety and efficacy.
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PMID:Use of modafinil in patients with epilepsy. 2255 84


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