title: A double-blind comparison of galantamine hydrogen bromide and placebo in adults with attention-deficit/hyperactivity disorder: a pilot study.
abstract: BACKGROUND
  Galantamine hydrogen bromide (HBr) is a competitive and reversible inhibitor of acetylcholinesterase. Because of its cholinergic nicotinic mechanism of action, galantamine HBr was hypothesized to have therapeutic activity in the treatment of attention-deficit/hyperactivity disorder (ADHD).
  
  
  METHODS
  We conducted a 12-week, double-blind, placebo-controlled, randomized clinical trial using daily doses of up to 24 mg/d of galantamine HBr in the treatment of adults who met full Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for ADHD with childhood-onset and persistent adult symptoms. All analyses were intention to treat with the last observation carried forward for subjects who did not complete the full study schedule.
  
  
  RESULTS
  The mean daily doses at week 12 were 19.8 +/- 6.4 mg for galantamine HBr and 21.8 +/- 4.6 mg for placebo (P = 0.3). There was no statistically or clinically significant greater reduction in ADHD symptoms in subjects treated with galantamine HBr relative to those receiving placebo (P = 0.5). Using last observation carried forward, 4 (22%) of 18 of patients receiving galantamine HBr were considered responders (much or very much improved on the Clinical Global Impression Improvement Scale and at least a 30% reduction on the ADHD Investigator Symptom Report Scale compared with 11% [2/18] on placebo; P = 0.4).
  
  
  CONCLUSIONS
  These results do not support the clinical utility of galantamine HBr in the treatment of ADHD at the doses used in this pilot study.
authors.affiliation: Clinical and Research Program, Pediatric Psychopharmacology, Massachusetts General Hospital, Boston, MA 02114, USA. jbiederman@partners.org
authors.forename: Joseph
authors.initials: J
authors.lastname: Biederman
authors.forename: Eric
authors.initials: E
authors.lastname: Mick
authors.forename: Stephen
authors.initials: S
authors.lastname: Faraone
authors.forename: Paul
authors.initials: P
authors.lastname: Hammerness
authors.forename: Craig
authors.initials: C
authors.lastname: Surman
authors.forename: Theresa
authors.initials: T
authors.lastname: Harpold
authors.forename: Meghan
authors.initials: M
authors.lastname: Dougherty
authors.forename: Megan
authors.initials: M
authors.lastname: Aleardi
authors.forename: Thomas
authors.initials: T
authors.lastname: Spencer
mesh_terms: D000293:Adolescent; D000328:Adult; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D002800:Cholinesterase Inhibitors / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005702:Galantamine / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010352:Patient Dropouts; D010865:Pilot Projects; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome
chemical_list: D002800:Cholinesterase Inhibitors; D010919:Placebos; D005702:Galantamine