title: Armodafinil in binge eating disorder: a randomized, placebo-controlled trial.
abstract: This study evaluated the efficacy, tolerability, and safety of armodafinil in the treatment of binge eating disorder (BED). Sixty participants with BED were randomized to receive armodafinil (150-250 mg/day) (N = 30) or placebo (N = 30) in a 10-week, prospective, parallel-group, double-blind, flexible-dose, single-center trial. In the primary longitudinal analysis, armodafinil and placebo produced similar rates of improvement in binge eating day frequency (the primary outcome measure); however, armodafinil was associated with a statistically significantly higher rate of decrease in binge eating episode frequency. In the secondary baseline-to-endpoint analyses, armodafinil was associated with statistically significant reductions in obsessive-compulsive features of binge eating and BMI. The mean (SD) armodafinil daily dose at endpoint evaluation was 216.7 (43.9) mg. There were no serious adverse events, although one armodafinil recipient developed markedly increased blood pressure that resolved upon drug discontinuation. The small sample size may have limited the detection of important drug-placebo differences. As some of the observed effect sizes appeared clinically meaningful, larger studies of armodafinil in the treatment of BED are warranted.
authors.affiliation: aLindner Center of HOPE, Mason bDepartment of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
authors.forename: Susan L
authors.initials: SL
authors.lastname: McElroy
authors.forename: Anna I
authors.initials: AI
authors.lastname: Guerdjikova
authors.forename: Nicole
authors.initials: N
authors.lastname: Mori
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Blom
authors.forename: Stephanie
authors.initials: S
authors.lastname: Williams
authors.forename: Leah S
authors.initials: LS
authors.lastname: Casuto
authors.forename: Paul E
authors.initials: PE
authors.lastname: Keck
mesh_terms: D000328:Adult; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D056912:Binge-Eating Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D001794:Blood Pressure / Q000187:drug effects; D015992:Body Mass Index; D004311:Double-Blind Method; D005247:Feeding Behavior / Q000187:drug effects*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000139:chemically induced / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D009820:Ohio; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001559:Benzhydryl Compounds; D000077408:Modafinil