A pilot controlled clinical trial of ABT-418, a cholinergic agonist, in the treatment of adults with attention deficit hyperactivity disorder.
OBJECTIVE
Despite the increasing recognition of attention deficit hyperactivity disorder (ADHD) in adults, there is a paucity of controlled pharmacological trials. Recent reports have suggested the potential usefulness of cholinergic agents for ADHD. To this end, the authors completed a controlled study of ABT-418, a novel cholinergic activating agent, for the treatment of adults with ADHD.


METHODS
This was a double-blind, placebo-controlled, randomized, crossover trial that compared a transdermal patch of ABT-418 (75 mg/day) to placebo in adults who met DSM-IV criteria for ADHD. There were two 3-week treatment periods separated by 1 week of washout.


RESULTS
Of the 32 subjects enrolled in the study (88% were men; mean age = 40 years, SD = 9), 29 completed the study. At the endpoint of each active arm (last observation carried forward), a significantly higher proportion of subjects was considered improved while receiving ABT-418 than while receiving placebo (40% versus 13%). Similarly, at endpoint there was a significantly greater reduction in ADHD symptom checklist scores (28% versus 15%). Symptoms reflective of attention, and subjects with less severe ADHD, responded more robustly to ABT-418. Treatment with ABT-418 was relatively well tolerated; dizziness and nausea were the most frequently reported adverse effects.


CONCLUSIONS
The results of this investigation indicate that ABT-418, a nicotinic analog, may be a potentially useful agent for the treatment of ADHD.
Wilens
T E
TE
Pediatric Psychopharmacology Clinic, Massachusetts General Hospital, Harvard Medical School, Boston 02114, USA. wilens@helix.mgh.harvard.edu
Biederman
J
J
Spencer
T J
TJ
Bostic
J
J
Prince
J
J
Monuteaux
M C
MC
Soriano
J
J
Fine
C
C
Abrams
A
A
Rater
M
M
Polisner
D
D
D000279:Administration, Cutaneous; D000328:Adult; D000367:Age Factors; D014151:Anti-Anxiety Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000523:psychology; D018679:Cholinergic Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D018592:Cross-Over Studies; D004244:Dizziness / Q000139:chemically induced; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D009325:Nausea / Q000139:chemically induced; D010865:Pilot Projects; D011759:Pyrrolidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D014151:Anti-Anxiety Agents; D018679:Cholinergic Agonists; D007555:Isoxazoles; D011759:Pyrrolidines; C088383:3-methyl-5-(1-methyl-2-pyrrolidinyl)isoxazole