Long-Term, Open-Label Safety and Efficacy of Atomoxetine in Adults With ADHD Final Report of a 4-Year Study

Objective: Previously, data from 97 weeks of open-label atomoxetine treatment of adults with attention-deficit/hyperactivity disorder (ADHD) were reported. This final report of that study presents results from over 4 years of treatment. Method: Results were derived from the study of 384 patients (125 patients remaining in the open-label trial since the interim report), receiving up to 221 weeks of treatment. Primary efficacy measure was the Conners'Adult ADHD Rating Scale-Investigator Rated: Screening Version (CAARS-Inv: SV) Total ADHD Symptom score. Adverse events and vital signs were assessed. Results: CAARS-Inv: SV Total ADHD Symptom scores decreased 30.2% (p < .001) during treatment. Similar, significant decreases were noted for the secondary efficacy measures, including the Sheehan Disability Scale Total score, which improved 25.3% (p < .001). Adverse events consisted primarily of pharmacologically (noradrenergic) expected effects. Conclusions: Results of this open-label study support the long-term efficacy, safety, and tolerability of atomoxetine for the treatment of adult ADHD. (J. of Att. Dis. 2008; 12(3) 248-253)