A pilot controlled clinical trial of ABT-418, a cholinergic agonist, in the treatment of adults with attention deficit hyperactivity disorder.

Abstract

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.

METHOD:

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.

• Authors: T E Wilens, J Biederman, T J Spencer, J Bostic, J Prince, M C Monuteaux, J Soriano, C Fine, A Abrams, M Rater, D Polisner
• Journal: The American journal of psychiatry (Am J Psychiatry) Vol. 156 Issue 12 Pg. 1931-7 (Dec 1999) ISSN: 0002-953X [Print] United States
• PMID: 10588407 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Anti-Anxiety Agents
• Cholinergic Agonists
• Isoxazoles
• Pyrrolidines
• 3-methyl-5-(1-methyl-2-pyrrolidinyl)isoxazole

Topics

• Administration, Cutaneous
• Adult
• Age Factors
• Anti-Anxiety Agents (administration & dosage, adverse effects, therapeutic use)
• Attention Deficit Disorder with Hyperactivity (drug therapy, psychology)
• Cholinergic Agonists (administration & dosage, adverse effects, therapeutic use)
• Cross-Over Studies
• Dizziness (chemically induced)
• Double-Blind Method
• Female
• Humans
• Isoxazoles (administration & dosage, adverse effects, therapeutic use)
• Male
• Nausea (chemically induced)
• Pilot Projects
• Pyrrolidines (administration & dosage, adverse effects, therapeutic use)
• Treatment Outcome