Long-term, open-label safety and efficacy of atomoxetine in adults with ADHD: final report of a 4-year study.
Author(s): Adler LA, Spencer TJ, Williams DW, Moore RJ, Michelson D
Affiliation(s): New York University, School of Medicine, New York, NY 10016, USA. email@example.com
Publication date & source: 2008-11, J Atten Disord., 12(3):248-53. Epub 2008 Apr 30.
Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
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.