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).
Method: 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).
Conclusion: These results do not support the clinical utility of galantamine HBr in the treatment of ADHD at the doses used in this pilot study.
*Clinical and Research Program, Pediatric Psychopharmacology, Massachusetts General Hospital, Boston, MA; †Department of Psychiatry, Harvard Medical School, Boston, MA; and ‡Department of Medical Genetics and Child and Adolescent Psychiatry Research, SUNY Upstate Medical University, Syracuse, NY.
This study was funded by Janssen Pharmaceuticals, Titusville, NJ.
Address correspondence and reprint requests to Joseph Biederman, MD, Pediatric Psychopharmacology Unit, Yawkey Center for Outpatient Care, YAW-6A-6900, Massachusetts General Hospital, 32 Fruit St, Boston, MA 02114. E-mail: firstname.lastname@example.org.