Cognitive effects of modafinil in patients with multiple sclerosis: A clinical trial

Rehabilitation Psychology

Volumn 61, Issue 1, 2016, Pages 82-91

  Ford Johnson, L ^a,b   DeLuca, J ^b   Zhang, J ^a   Elovic, E ^a   Lengenfelder, J ^c   Chiaravalloti, N D ^b  

^a KESSLER FOUNDATION   (United States)

^b RUTGERS UNIVERSITY   (United States)

^c Healthsouth Rehabilitation Hospital   (United States)

Author keywords

Cognitive effects; Learning; Memory; Modafinil; Multiple sclerosis

Indexed keywords

MODAFINIL; PLACEBO; BENZHYDRYL DERIVATIVE; WAKEFULNESS PROMOTING AGENT;

ADULT; ARTICLE; CLINICAL ARTICLE; COGNITION; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; FATIGUE; FATIGUE IMPACT SCALE; FATIGUE SEVERITY SCALE; FEMALE; HUMAN; LEARNING; LEARNING DISORDER; MALE; MULTIPLE SCLEROSIS; RANDOMIZED CONTROLLED TRIAL; SELF REPORT; SINGLE DRUG DOSE; TASK PERFORMANCE; WECHSLER ADULT INTELLIGENCE SCALE; WORKING MEMORY; COGNITION DISORDERS; COMPLICATION; DRUG EFFECTS; MEMORY DISORDERS; TREATMENT OUTCOME;

ADULT; BENZHYDRYL COMPOUNDS; COGNITION; COGNITION DISORDERS; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; FATIGUE; HUMANS; MEMORY DISORDERS; MULTIPLE SCLEROSIS; TREATMENT OUTCOME; WAKEFULNESS-PROMOTING AGENTS;

EID: 84958916709     PISSN: 00905550     EISSN: 19391544     Source Type: Journal    
DOI: 10.1037/a0039919     Document Type: Article

References (77)

1. Barak, Y., & Achiron, A. (2002). Effect of interferon-beta-1b on cognitive functions in multiple sclerosis. European Neurology, 47, 11-14. http://dx.doi.org/10.1159/000047940
2. Beatty, W. W., Krull, K. R., Wilbanks, S. L., Blanco, C. R., Hames, K. A., & Paul, R. H. (1996). Further validation of constructs from the selective reminding test. Journal of Clinical and Experimental Neuropsychology, 18, 52-55. http://dx.doi.org/10.1080/01688639608408261
3. Becker, B. E., & DeLisa, J. A. (1999). Model spinal cord injury system trends, and implications for the future. Archives of Physical Medicine Rehabilitation, 80, 1514-1521.
4. Becker, P. M., Schwartz, J. R. L., Feldman, N. T., & Hughes, R. J. (2004). Effect of modafinil on fatigue, mood, and health-related quality of life in patients with narcolepsy. Psychopharmacology, 171, 133-139. http://dx.doi.org/10.1007/s00213-003-1508-9
5. Beusterien, K. M., Rogers, A. E., Walsleben, J. A., Emsellem, H. A., Reblando, J. A., Wang, L., Steinwald, B. (1999). Health-related quality of life effects of modafinil for treatment of narcolepsy. Sleep: Journal of Sleep Research & Sleep Medicine, 22, 757-765.
6. Boller, F., & Vignolo, L. A. (1966). Latent sensory aphasia in hemispheredamaged patients: An experimental study with the Token Test. Brain: A Journal of Neurology, 89, 815-830. http://dx.doi.org/10.1093/brain/89.4.815
7. Buschke, H., & Fuld, P. A. (1974). Evaluating storage, retention, and retrieval in disordered memory and learning. Neurology, 24, 1019-1025. http://dx.doi.org/10.1212/WNL.24.11.1019
8. Chiaravalloti, N. D., Balzano, J., Moore, N. B., & DeLuca, J. (Eds.). (2009). The open-trial selective reminding test (OT-SRT) as a tool for the assessment of learning and memory (edited vol. 23).
9. Chiaravalloti, N. D., & DeLuca, J. (2008). Cognitive impairment in multiple sclerosis. The Lancet Neurology, 7, 1139-1151. http://dx.doi.org/10.1016/S1474-4422(08)70259-X
10. Christodoulou, C., Melville, P., Scherl, W. F., Macallister, W. S., Elkins, L. E., & Krupp, L. B. (2006). Effects of donepezil on memory and cognition in multiple sclerosis. Journal of the Neurological Sciences, 245, 127-136. http://dx.doi.org/10.1016/j.jns.2005.08.021
11. Cohen, J. A., Cutter, G. R., Fischer, J. S., Goodman, A. D., Heidenreich, F. R., Kooijmans, M. F., the IMPACT Investigators. (2002). Benefit of interferon beta-1a on MSFC progression in secondary progressive MS. Neurology, 59, 679-687. http://dx.doi.org/10.1212/WNL.59.5.679
12. DeBattista, C., Doghramji, K., Menza, M. A., Rosenthal, M. H., & Fieve, R. R. (2003). Adjunct modafinil for the short-term treatment of fatigue and sleepiness in patients with major depressive disorder: A preliminary double-blind, placebo-controlled study. Journal of Clinical Psychiatry, 64, 1057-1064. http://dx.doi.org/10.4088/JCP.v64n0911
13. Delis, D. C., Kramer, J., Kaplan, E., & Ober, B. (Eds.). (1987). The California verbal learning test. New York, NY: The Psychological Corporation.
14. Delis, D. C., Kramer, J., Kaplan, E., & Ober, B. (Eds.). (2000). The California verbal learning test (2nd ed.). New York, NY: The Psychological Corporation.
15. DeLuca, J., Barbieri-Berger, S., & Johnson, S. K. (1994). The nature of memory impairments in multiple sclerosis: Acquisition versus retrieval. Journal of Clinical and Experimental Neuropsychology, 16, 183-189. http://dx.doi.org/10.1080/01688639408402629
16. DeLuca, J., Gaudino, E. A., Diamond, B. J., Christodoulou, C., & Engel, R. A. (1998). Acquisition and storage deficits in multiple sclerosis. Journal of Clinical and Experimental Neuropsychology, 20, 376-390. http://dx.doi.org/10.1076/jcen.20.3.376.819
17. Demaree, H. A., Gaudino, E. A., DeLuca, J., & Ricker, J. H. (2000). Learning impairment is associated with recall ability in multiple sclerosis. Journal of Clinical and Experimental Neuropsychology, 22, 865-873. http://dx.doi.org/10.1076/jcen.22.6.865.961
18. Elliott, R., Sahakian, B. J., Matthews, K., Bannerjea, A., Rimmer, J., & Robbins, T. W. (1997). Effects of methylphenidate on spatial working memory and planning in healthy young adults. Psychopharmacology, 131, 196-206. http://dx.doi.org/10.1007/s002130050284
19. Engber, T. M., Koury, E. J., Dennis, S. A., Miller, M. S., Contreras, P. C., & Bhat, R. V. (1998). Differential patterns of regional c-Fos induction in the rat brain by amphetamine and the novel wakefulness-promoting agent modafinil. Neuroscience Letters, 241, 95-98. http://dx.doi.org/10.1016/S0304-3940(97)00962-2
20. Finke, K., Dodds, C. M., Bublak, P., Regenthal, R., Baumann, F., Manly, T., & Müller, U. (2010). Effects of modafinil and methylphenidate on visual attention capacity: A TVA-based study. Psychopharmacology, 210, 317-329. http://dx.doi.org/10.1007/s00213-010-1823-x
21. Fisher, E., Rudick, R. A., Cutter, G., Baier, M., Miller, D., Weinstock-Guttman, B., Simonian, N. A. (2000). Relationship between brain atrophy and disability: An 8-year follow-up study of multiple sclerosis patients. Multiple Sclerosis, 6, 373-377. http://dx.doi.org/10.1177/135245850000600602
22. Fisk, J. D., Pontefract, A., Ritvo, P. G., Archibald, C. J., & Murray, T. J. (1994). The impact of fatigue on patients with multiple sclerosis. The Canadian Journal of Neurological Sciences, 21, 9-14.
23. Fisk, J. D., Ritvo, P. G., Ross, L., Haase, D. A., Marrie, T. J., & Schlech, W. F. (1994). Measuring the functional impact of fatigue: Initial validation of the fatigue impact scale. Clinical Infectious Diseases, 18, S79-S83. http://dx.doi.org/10.1093/clinids/18.Supplement_1.S79
24. Flechter, S., Vardi, J., Finkelstein, Y., & Pollak, L. (2007). Cognitive dysfunction evaluation in multiple sclerosis patients treated with interferon beta-1b: An open-label prospective 1 year study. The Israel Medical Association Journal, 9, 457-459.
25. Genova, H. M., Hillary, F. G., Wylie, G., Rypma, B., & DeLuca, J. (2009). Examination of processing speed deficits in multiple sclerosis using functional magnetic resonance imaging. Journal of the International Neuropsychological Society, 15, 383-393. http://dx.doi.org/10.1017/S1355617709090535
26. Ghahremani, D. G., Tabibnia, G., Monterosso, J., Hellemann, G., Poldrack, R. A., & London, E. D. (2011). Effect of modafinil on learning and task-related brain activity in methamphetamine-dependent and healthy individuals. Neuropsychopharmacology, 36, 950-959. http://dx.doi.org/10.1038/npp.2010.233
27. Gilewski, M. J., Zelinski, E. M., & Schaie, K. W. (1990). The Memory Functioning Questionnaire for assessment of memory complaints in adulthood and old age. Psychology and Aging, 5, 482-490. http://dx.doi.org/10.1037/0882-7974.5.4.482
28. Grant, I., Prigatano, G. P., Heaton, R. K., McSweeny, A. J., Wright, E. C., & Adams, K. M. (1987). Progressive neuropsychologic impairment and hypoxemia. Relationship in chronic obstructive pulmonary disease. Archives of General Psychiatry, 44, 999-1006. http://dx.doi.org/10.1001/archpsyc.1987.01800230079013
29. Greene, Y. M., Tariot, P. N., Wishart, H., Cox, C., Holt, C. J., Schwid, S., & Noviasky, J. (2000). A 12-week, open trial of donepezil hydrochloride in patients with multiple sclerosis and associated cognitive impairments. Journal of Clinical Psychopharmacology, 20, 350-356. http://dx.doi.org/10.1097/00004714-200006000-00010
30. Harel, Y., Appleboim, N., Lavie, M., & Achiron, A. (2009). Single dose of methylphenidate improves cognitive performance in multiple sclerosis patients with impaired attention process. Journal of the Neurological Sciences, 276, 38-40. http://dx.doi.org/10.1016/j.jns.2008.08.025
31. Hunter, M. D., Ganesan, V., Wilkinson, I. D., & Spence, S. A. (2006). Impact of modafinil on prefrontal executive unction in chronic schizophrenia. American Journal of Psychiatry, 163, 2184-2186.
32. Jones, R. W., Soininen, H., Hager, K., Aarsland, D., Passmore, P., Murthy, A., Bahra, R. (2004). A multinational, randomised, 12-week study comparing the effects of donepezil and galantamine in patients with mild to moderate Alzheimer's disease. International Journal of Geriatric Psychiatry, 19, 58-67. http://dx.doi.org/10.1002/gps.1038
33. Kappos, L., Freedman, M. S., Polman, C. H., Edan, G., Hartung, H. P., Miller, D. H., the BENEFIT Study Group. (2009). Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial. The Lancet Neurology, 8, 987-997. http://dx.doi.org/10.1016/S1474-4422(09)70237-6
34. Kelland, D. Z., & Lewis, R. F. (1994). Evaluation of the reliability and validity of the repeatable cognitive-perceptual-motor battery. Clinical Neuropsychologist, 8, 295-308. http://dx.doi.org/10.1080/13854049408404136
35. Khateb, A., Ammann, J., Annoni, J. M., & Diserens, K. (2005). Cognitionenhancing effects of donepezil in traumatic brain injury. European Neurology, 54, 39-45. http://dx.doi.org/10.1159/000087718
36. Kohli, S., Fisher, S. G., Tra, Y., Adams, M. J., Mapstone, M. E., Wesnes, K. A., Morrow, G. R. (2009). The effect of modafinil on cognitive function in breast cancer survivors. Cancer, 115, 2605-2616. http://dx.doi.org/10.1002/cncr.24287
37. Krupp, L. B., Christodoulou, C., Melville, P., Scherl, W. F., Pai, L. Y., Muenz, L. R., Wishart, H. (2011). Multicenter randomized clinical trial of donepezil for memory impairment in multiple sclerosis. Neurology, 76, 1500-1507. http://dx.doi.org/10.1212/WNL.0b013e318218107a
38. Krupp, L. B., LaRocca, N. G., Muir-Nash, J., & Steinberg, A. D. (1989). The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Archives of Neurology, 46, 1121-1123. http://dx.doi.org/10.1001/archneur.1989.00520460115022
39. Lange, R., Volkmer, M., Heesen, C., & Liepert, J. (2009). Modafinil effects in multiple sclerosis patients with fatigue. Journal of Neurology, 256, 645-650. http://dx.doi.org/10.1007/s00415-009-0152-7
40. Lewis, R. D., & Rennick, P. M. (1979). The manual for the repeatable cognitive perceptual-motor battery. Clinton Township, MI: Ronald F Lewis.
41. McLaren, D. G., Sreenivasan, A., Diamond, E. L., Mitchell, M. B., Van Dijk, K. R., DeLuca, A. N., Atri, A. (2012). Tracking cognitive change over 24 weeks with longitudinal functional magnetic resonance imaging in Alzheimer's disease. Neurodegenerative Diseases, 9, 176-186. http://dx.doi.org/10.1159/000335876
42. Minden, S. L., & Moes, E. J. (1990). A psychiatric perspective. In S. Rao (Ed.), Neurobehavioral aspects of multiple sclerosis (pp. 230-250). Boston, MA: Oxford University Press.
43. Minzenberg, M. J., & Carter, C. S. (2008). Modafinil: A review of neurochemical actions and effects on cognition. Neuropsychopharmacology, 33, 1477-1502. http://dx.doi.org/10.1038/sj.npp.1301534
44. Müller, U., Steffenhagen, N., Regenthal, R., & Bublak, P. (2004). Effects of modafinil on working memory processes in humans. Psychopharmacology, 177, 161-169. http://dx.doi.org/10.1007/s00213-004-1926-3
45. National Multiple Sclerosis Society. (2010). Retrieved from http://www.nationalmssociety.org/about-multiple-sclerosis/what-we-know-about-ms/faqs-about-ms/index.aspx
46. Niederhofer, H. (2006). Donepezil in the treatment of narcolepsy. Journal of Clinical Sleep Medicine, 2, 71-72.
47. Nyenhuis, D. L., & Luchetta, T. (1998). The development, standardization, and initial validation of the Chicago Multiscale Depression Inventory. Journal of Personality Assessment, 70, 386-401. http://dx.doi.org/10.1207/s15327752jpa7002_14
48. O'Brien, A. R., Chiaravalloti, N., Goverover, Y., & DeLuca, J. (2008). Evidenced-based cognitive rehabilitation for persons with multiple sclerosis: A review of the literature. Archives of Physical Medicine and Rehabilitation, 89, 761-769.
49. Packard, M. G., & Goodman, J. (2012). Emotional arousal and multiple memory systems in the mammalian brain. Frontiers in Behavioral Neuroscience, 6, 14. http://dx.doi.org/10.3389/fnbeh.2012.00014
50. Penner, I. K., Stemper, B., Calabrese, P., Freedman, M. S., Polman, C. H., Edan, G., Sandbrink, R. (2012). Effects of interferon beta-1b on cognitive performance in patients with a first event suggestive of multiple sclerosis. Multiple Sclerosis, 18, 1466-1471. http://dx.doi.org/10.1177/1352458512442438
51. Rammohan, K. W., Rosenberg, J. H., Lynn, D. J., Blumenfeld, A. M., Pollak, C. P., & Nagaraja, H. N. (2002). Efficacy and safety of modafinil (Provigil) for the treatment of fatigue in multiple sclerosis: A two centre phase 2 study. Journal of Neurology, Neurosurgery, and Psychiatry, 72, 179-183. http://dx.doi.org/10.1136/jnnp.72.2.179
52. Rasetti, R., Mattay, V. S., Stankevich, B., Skjei, K., Blasi, G., Sambataro, F., Weinberger, D. R. (2010). Modulatory effects of modafinil on neural circuits regulating emotion and cognition. Neuropsychopharmacology, 35, 2101-2109. http://dx.doi.org/10.1038/npp.2010.83
53. Rosene, K. A., Copass, M. K., Kastner, L. S., Nolan, C. M., & Eschenbach, D. A. (1982). Persistent neuropsychological sequelae of toxic shock syndrome. Annals of Internal Medicine, 96, 865-870. http://dx.doi.org/10.7326/0003-4819-96-6-865
54. Rosenthal, M. H., & Bryant, S. L. (2004). Benefits of adjunct modafinil in an open-label, pilot study in patients with schizophrenia. Clinical Neuropharmacology, 27, 38-43. http://dx.doi.org/10.1097/00002826-200401000-00011
55. Rugino, T. A., & Copley, T. C. (2001). Effects of modafinil in children with attention-deficit/hyperactivity disorder: An open-label study. Journal of the American Academy of Child & Adolescent Psychiatry, 40, 230-235. http://dx.doi.org/10.1097/00004583-200102000-00018
56. Saletu, B., Saletu, M., Grünberger, J., Frey, R., Anderer, P., & Mader, R. (1993). Treatment of the alcoholic organic brain syndrome: Doubleblind, placebo-controlled clinical, psychometric and electroencephalographic mapping studies with modafinil. Neuropsychobiology, 27, 26-39. http://dx.doi.org/10.1159/000118950
57. Saletu, M., Anderer, P., Saletu-Zyhlarz, G. M., Mandl, M., Saletu, B., & Zeitlhofer, J. (2009). Modafinil improves information processing speed and increases energetic resources for orientation of attention in narcoleptics: Double-blind, placebo-controlled ERP studies with lowresolution brain electromagnetic tomography (LORETA). Sleep Medicine, 10, 850-858. http://dx.doi.org/10.1016/j.sleep.2008.12.005
58. Schwid, S. R., Goodman, A. D., Weinstein, A., McDermott, M. P., & Johnson, K. P. (2007). Cognitive function in relapsing multiple sclerosis: Minimal changes in a 10-year clinical trial. Journal of Neurology Science, 255, 57-63. http://dx.doi.org/10.1016/j.jns.2007.01.070
59. Selzer, M. L. (1971). The Michigan Alcoholism Screening Test: The quest for a new diagnostic instrument. The American Journal of Psychiatry, 127, 1653-1658. http://dx.doi.org/10.1176/ajp.127.12.1653
60. Smith, A. (1982). Symbol digit modalities test (SDMT). Los Angeles, CA: Western Psychological Services.
61. Spence, S. A., Green, R. D., Wilkinson, I. D., & Hunter, M. D. (2005). Modafinil modulates anterior cingulate function in chronic schizophrenia. The British Journal of Psychiatry, 187, 55-61. http://dx.doi.org/10.1192/bjp.187.1.55
62. Spielberger, C. D. (Ed.). (1983). The manual for the state-trait anxiety inventory. Menlo Park, CA: Mind Garden Publishers.
63. Squire, L. R. (2004). Memory systems of the brain: A brief history and current perspective. Neurobiology of Learning and Memory, 82, 171-177. http://dx.doi.org/10.1016/j.nlm.2004.06.005
64. Strauss, E., Sherman, E., & Spreen, O. (Eds.). (1998). A compendium of neuropsychological tests. New York, NY: Oxford University Press.
65. Strauss, E., Sherman, E., & Spreen, O. (Eds.). (2006). A compendium of neuropsychological tests (3rd ed.). New York, NY: Oxford University Press.
66. Sumowski, J. F., Chiaravalloti, N., Erlanger, D., Kaushik, T., Benedict, R. H., & DeLuca, J. (2011). L-amphetamine improves memory in MS patients with objective memory impairment. Multiple Sclerosis, 17, 1141-1145. http://dx.doi.org/10.1177/1352458511404585
67. Taylor, F. B., & Russo, J. (2000). Efficacy of modafinil compared to dextroamphetamine for the treatment of attention deficit hyperactivity disorder in adults. Journal of Child and Adolescent Psychopharmacology, 10, 311-320. http://dx.doi.org/10.1089/cap.2000.10.311
68. Thomas, S. J., & Grossberg, G. T. (2009). Memantine: A review of studies into its safety and efficacy in treating Alzheimer's disease and other dementias. Clinical Interventions in Aging, 4, 367-377.
69. Turner, D. C., Clark, L., Pomarol-Clotet, E., McKenna, P., Robbins, T. W., & Sahakian, B. J. (2004). Modafinil improves cognition and attentional set shifting in patients with chronic schizophrenia. Neuropsychopharmacology, 29, 1363-1373.
70. Turner, D. C., Robbins, T. W., Clark, L., Aron, A. R., Dowson, J., & Sahakian, B. J. (2003). Cognitive enhancing effects of modafinil in healthy volunteers. Psychopharmacology, 165, 260-269.
71. Vickrey, B. G., Hays, R. D., Genovese, B. J., Myers, L. W., & Ellison, G. W. (1997). Comparison of a generic to disease-targeted health-related quality-of-life measures for multiple sclerosis. Journal of Clinical Epidemiology, 50, 557-569.
72. Vickrey, B. G., Hays, R. D., Harooni, R., Myers, L. W., & Ellison, G. W. (1995). A health-related quality of life measure for multiple sclerosis. Quality of Life Research: An International Journal of Quality of Life Aspects of Treatment, Care & Rehabilitation, 4, 187-206. http://dx.doi.org/10.1007/BF02260859
73. Wechsler, D. (1997). Wechsler Adult Intelligence Scale (3rd ed.). New York, NY: The Psychological Corporation.
74. Wesensten, N. J., Killgore, W. D., & Balkin, T. J. (2005). Performance and alertness effects of caffeine, dextroamphetamine, and modafinil during sleep deprivation. Journal of Sleep Research, 14, 255-266. http://dx.doi.org/10.1111/j.1365-2869.2005.00468.x
75. Wilkinson, D., Róman, G., Salloway, S., Hecker, J., Boundy, K., Kumar, D., Schindler, R. (2010). The long-term efficacy and tolerability of donepezil in patients with vascular dementia. International Journal of Geriatric Psychiatry, 25, 305-313. http://dx.doi.org/10.1002/gps.2340
76. Yantz, C. L., Johnson-Greene, D., Higginson, C., & Emmerson, L. (2010). Functional cooking skills and neuropsychological functioning in patients with stroke: An ecological validity study. Neuropsychological Rehabilitation, 20, 725-738. http://dx.doi.org/10.1080/09602011003765690
77. Zifko, U. A., Rupp, M., Schwarz, S., Zipko, H. T., & Maida, E. M. (2002). Modafinil in treatment of fatigue in multiple sclerosis. Journal of Neurology, 249, 983-987. http://dx.doi.org/10.1007/s00415-002-0765-6