12 Aug Modafinil treatment for fatigue in HIV+ patients: a pilot study
Background: Fatigue is widespread among human immunodeficiency virus-positive (HIV+) patients, yet few studies have assessed effective treatments. The authors conducted a pilot study to evaluate the efficacy of Modafinil for fatigue in this clinical population.
Method: Response was evaluated after a 4-week open-label trial. Data were collected from February 2003 through January 2004. Responders were offered 8 additional weeks of modafinil. Inclusion criteria included written approval from the primary care physician, clinically significant fatigue, current use of anti-retroviral medications, and the absence of treatable medical conditions known to cause fatigue. Exclusion criteria included untreated major depression and current substance abuse. Major outcome measures were the Fatigue Severity Scale, Chalder Fatigue Scale, Hamilton Rating Scale for Depression, Beck Depression Inventory, and neuropsychological tests assessing verbal memory, speed of processing, and executive function. Immunologic and virologic measures were performed at baseline and week 4 to assess safety of treatment.
Results: All 30 patients who enrolled completed 4 weeks of treatment; 24 (80%) were rated as responders. Responders showed statistically significant improvement on all measures of fatigue, depressive symptoms, and executive function, while nonresponders did not. Mean values of CD4 cell count and HIV RNA viral load did not change. The most common side effect was headache, followed by irritability and feeling “hyper.”
Conclusion: This pilot study shows encouraging results for modafinil in alleviation of fatigue in HIV+ patients. In addition, depressive symptoms were substantially reduced. Improvements on measures of verbal memory and executive function were significant, but in the absence of a placebo control, the magnitude of effect due to practice cannot be determined.
1. Modafinil Improves Episodic Memory and Working Memory Cognition in Patients With Remitted Depression: A Double-Blind, Randomized, Placebo-Controlled Study. Muzaffer Kaser, Julia B Deakin , Albert Michael , Camilo Zapata , Rachna Bansal , Dragana Ryan , Francesca Cormack , James B Rowe , Barbara J Sahakian.
2. Cognitive enhancing effects of modafinil in healthy volunteers. Danielle C. Turner, Trevor W. Robbins, Luke Clark, Adam R. Aron, Jonathan Dowson & Barbara J. Sahakian.
3. Modafinil improves attentional performance in healthy, non-sleep deprived humans at doses not inducing hyperarousal across species. Zackary A.Cope, Arpi Minassian, DustinKreitner, David A. MacQueen, MorganeMilienne-Petiot, Mark A.Geyer, WilliamPerry, Jared W.Young.
4. Effects of modafinil on cognitive performance and alertness during sleep deprivation. Wesensten, Nancy J.
5. A phase 3 randomized, placebo-controlled, double-blind, clinical trial of the effect of modafinil on cancer-related fatigue among 631 patients receiving chemotherapy: a University of Rochester Cancer Center Community Clinical Oncology Program Research bas. Pascal Jean-Pierre 1, Gary R Morrow, Joseph A Roscoe, Charles Heckler, Supriya Mohile, Michelle Janelsins, Luke Peppone, Amy Hemstad, Benjamin T Esparaz, Judith O Hopkins.
6. Modafinil. Karl Greenblatt, Ninos Adams.
7. Modafinil reduces depression’s severity when taken with antidepressants. Barbara Sahakian, Dr Muzaffer Kaser.
8. Long-term safety and efficacy of armodafinil in bipolar depression: A 6-month open-label extension study. Terence A.Ketter, JessAmchin, Mark A.Frye, NicholasGross.
9. Modafinil treatment in patients with seasonal affective disorder/winter depression: an open-label pilot study. LeslieLundt.
10. Modafinil and Memory: Effects of Modafinil on Morris Water Maze Learning and Pavlovian Fear Conditioning. Tristan Shuman, Suzanne C. Wood, and Stephan G. Anagnostaras.
12. School of Health Sciences. Wharrad, Heather.
13. FDA basics.
14. United States Drug Enforcement Administration.
15. Drug Scheduling. DEA.
16. Is modafinil safe in the long term? Cox, David.
17. Modafinil treatment for fatigue in HIV+ patients: a pilot study. Judith G Rabkin 1, Martin C McElhiney, Richard Rabkin, Stephen J Ferrando.