title: A randomized trial of modafinil for the treatment of fatigue and excessive daytime sleepiness in individuals with chronic traumatic brain injury.
abstract: BACKGROUND
  This study examines the efficacy of modafinil in treating fatigue and excessive daytime sleepiness in individuals with traumatic brain injury (TBI).
  
  
  METHODS
  A single-center, double-blind, placebo-controlled cross-over trial, where 53 participants with TBI were randomly assigned to receive up to 400 mg of modafinil, or equal number of inactive placebo tablets. Main eligibility criteria were being at least 1 year post-TBI severe enough to require inpatient rehabilitation. The primary outcome measures were fatigue (Fatigue Severity Scale, FSS) and daytime sleepiness (Epworth Sleepiness Scale, ESS).
  
  
  RESULTS
  After adjusting for baseline scores and period effects, there were no statistically significant differences between improvements seen with modafinil and placebo in the FSS at week 4 (-0.5 +/- 1.88; P = .80) or week 10 (-1.4 +/- 2.75; P = .61). For ESS, average changes were significantly greater with modafinil than placebo at week 4 (-1.2 +/- 0.49; P = .02) but not at week 10 (-0.5 +/- 0.87; P = .56). Modafinil was safe and well tolerated, although insomnia was reported significantly more often with modafinil than placebo (P = .03).
  
  
  CONCLUSIONS
  While there were sporadic statistically significant differences identified, a clear beneficial pattern from modafinil was not seen at either week 4 or week 10 for any of the 12 outcomes. There was no consistent and persistent clinically significant difference between treatment with modafinil and placebo.
authors.affiliation: Craig Hospital, Research Department, Englewood, CO 80110, USA. ajha@craighospital.org
authors.forename: Amitabh
authors.initials: A
authors.lastname: Jha
authors.forename: Alan
authors.initials: A
authors.lastname: Weintraub
authors.forename: Amanda
authors.initials: A
authors.lastname: Allshouse
authors.forename: Clare
authors.initials: C
authors.lastname: Morey
authors.forename: Chris
authors.initials: C
authors.lastname: Cusick
authors.forename: John
authors.initials: J
authors.lastname: Kittelson
authors.forename: Cynthia
authors.initials: C
authors.lastname: Harrison-Felix
authors.forename: Gale
authors.initials: G
authors.lastname: Whiteneck
authors.forename: Don
authors.initials: D
authors.lastname: Gerber
mesh_terms: D000328:Adult; D001559:Benzhydryl Compounds / Q000008:administration & dosage*; D001930:Brain Injuries / Q000150:complications*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage*; D002908:Chronic Disease; D004311:Double-Blind Method; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D015601:Injury Severity Score; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D020178:Sleep Disorders, Circadian Rhythm; D016896:Treatment Outcome
chemical_list: D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D000077408:Modafinil