title: A 9-week, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study to evaluate the efficacy and safety of modafinil as treatment for adults with ADHD.
abstract: OBJECTIVE
  This study evaluated the efficacy and tolerability of modafinil at a range of doses, versus placebo, in alleviating symptoms of ADHD in adults.
  
  
  METHODS
  Adult patients with ADHD were randomized in 1:1:1:1:1 fashion to double-blind treatment with modafinil 255, 340, 425, or 510 mg daily or placebo for 9 weeks. The primary efficacy outcome was the change from baseline at final visit in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score.
  
  
  RESULTS
  A total of 338 patients were enrolled, of whom 330 received at least 1 dose of study medication (modafinil or placebo). No statistically significant difference in the AISRS total score was observed at final visit between any modafinil group and placebo; however, some observations among patients who completed the trial may warrant further investigation.
  
  
  CONCLUSIONS
  Modafinil was reasonably tolerated but did not demonstrate a benefit on ADHD symptoms in adults.
authors.affiliation: 1University of Tennessee Health Science Center, Memphis, USA.
authors.forename: Valerie K
authors.initials: VK
authors.lastname: Arnold
authors.forename: David
authors.initials: D
authors.lastname: Feifel
authors.forename: Craig Q
authors.initials: CQ
authors.lastname: Earl
authors.forename: Ronghua
authors.initials: R
authors.lastname: Yang
authors.forename: Lenard A
authors.initials: LA
authors.lastname: Adler
mesh_terms: D000328:Adult; D000368:Aged; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy*; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D011569:Psychiatric Status Rating Scales; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D064690:Wakefulness-Promoting Agents / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D001559:Benzhydryl Compounds; D064690:Wakefulness-Promoting Agents; D000077408:Modafinil