Published online November 13, 2006
PEDIATRICS Vol. 118 No. 6 December 2006, pp. e1701-e1706 (doi:10.1542/peds.2005-2999)
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow P3Rs: Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when P3Rs are posted
Right arrow Alert me if a correction is posted
Services
Right arrow E-mail this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My File Cabinet
Right arrow Download to citation manager
Right arrow reprints & permissions
Citing Articles
Right arrow Citing Articles via CrossRef
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Newcorn, J. H.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Newcorn, J. H.
Related Collections
Right arrow Neurology & Psychiatry

ARTICLE

Low-Dose Atomoxetine for Maintenance Treatment of Attention-Deficit/Hyperactivity Disorder

Jeffrey H. Newcorn, MDa, David Michelson, MDb, Christopher J. Kratochvil, MDc, Albert J. Allen, MD, PhDb, Dustin D. Ruff, PhDb, Rodney J. Moore, PhDb for the Atomoxetine Low-dose Study Group

a Department of Psychiatry, Mount Sinai Medical Center, New York, New York
b Lilly Research Laboratories, Indianapolis, Indiana
c Department of Psychiatry, University of Nebraska Medical Center, Omaha, Nebraska

OBJECTIVE. Data from acute studies of atomoxetine in patients with attention-deficit/hyperactivity disorder suggest that a dose of ~1.2 mg/kg per day is required to attain a maximal symptom response. However, lower doses could be effective during maintenance treatment, which would reduce drug exposure and potential problems related to tolerability during chronic treatment.

METHODS. Patients 6 to 16 years of age who had a robust response to an initial acute trial of atomoxetine were assigned randomly under double-blind conditions to continue treatment for up to 8 months with either the dose to which they had responded acutely (1.2–1.8 mg/kg per day, N = 116, continued same dose) or a lower dose (0.5 mg/kg per day, N = 113, low dose). The primary outcome measure was relapse, defined as an Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored total score returned to ≥90% of the original baseline value (before acute treatment) for 2 consecutive visits. Mean change in Attention-Deficit/Hyperactivity Disorder Rating Scale total score was assessed as a secondary outcome.

RESULTS. At randomization, symptom severity was low and similar in both groups. At end point, relapse rates did not differ between the groups. Mean change in Attention-Deficit/Hyperactivity Disorder Rating Scale total score from the conclusion of acute treatment to end point also was not different between groups. Reports of affective lability were higher in the patients in the low-dose group. Also, increases in heart rate (compared with when atomoxetine was started) were higher in the patients in the continued same-dose group than in the low-dose group. Finally, increases in weight over the course of the trial were greater for the low-dose group than the continued same-dose group.

CONCLUSIONS. For patients who experience a robust response to atomoxetine, it may be possible to retain the response during maintenance treatment with a reduced dose of atomoxetine.

Key Words: atomoxetine • ADHD • dose • maintenance treatment

Abbreviations: ADHD—attention-deficit/hyperactivity disorder • K-SADS-PL—Kiddie Schedule for Affective Disorders and Schizophrenia for School-Aged Children-Present and Lifetime Version • ADHD RS—Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored • CGI-ADHD-S—Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity • CHQ—Child Health Questionnaire

Accepted Jun 15, 2006.