A double-blind comparison of galantamine hydrogen bromide and placebo in adults with attention-deficit/hyperactivity disorder: a pilot study.
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.
Biederman
Joseph
J
Clinical and Research Program, Pediatric Psychopharmacology, Massachusetts General Hospital, Boston, MA 02114, USA. jbiederman@partners.org
Mick
Eric
E
Faraone
Stephen
S
Hammerness
Paul
P
Surman
Craig
C
Harpold
Theresa
T
Dougherty
Meghan
M
Aleardi
Megan
M
Spencer
Thomas
T
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
D002800:Cholinesterase Inhibitors; D010919:Placebos; D005702:Galantamine