Long-Term, Open-Label Study of the Safety and Efficacy of Atomoxetine in Adults With Attention-Deficit/Hyperactivity Disorder: An Interim Analysis
J Clin Psychiatry 2005;66(3):294-299
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disorder (ADHD) is an early-onset neuropsychiatric disorder that
affects 3% to 7% of school-age children and 4% of adults. Its
pathophysiology is thought to involve the dopaminergic and
noradrenergic pathways associated with attention control and
impulsivity. These symptoms have largely been defined in the
childhood population, but the course of the condition and
expression in the adult population are not as well characterized.
Method: This is an ongoing, 3-year, open-label
study consisting of adults with DSM-IV ADHD who were previously
enrolled in 1 of 2 double-blind, acute-treatment studies of
atomoxetine. The results of the interim analysis reported here
were derived from the study of 384 patients at 31 sites who had
been studied for a period of up to 97 weeks. The primary efficacy
measure was the Conners' Adult ADHD Rating Scale-Investigator
Rated: Screening Version (CAARS-Inv:SV) total ADHD symptom score.
In addition, safety, adverse events, and vital sign measurements
Results: Significant improvement was noted with
atomoxetine therapy, with mean CAARS-Inv:SV total ADHD symptom
scores decreasing 33.2% from 29.2 (baseline of open-label
therapy) to 19.5 (endpoint of open-label therapy) (p < .001).
Similar and significant decreases were noted for the secondary
efficacy measures. Adverse events consisted primarily of
pharmacologically (noradrenergic) expected effects, such as
increases in heart rate and blood pressure and a slight decrease
Conclusion: The results of this interim analysis
of an ongoing, open-label study of adults with ADHD support the
long-term efficacy, safety, and tolerability of atomoxetine for
the treatment of adult ADHD.