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An open-label, dose-titration tolerability study of atomoxetine hydrochloride in Japanese adults with attention-deficit/hyperactivity disorder
| Title: | An open-label, dose-titration tolerability study of atomoxetine hydrochloride in Japanese adults with attention-deficit/hyperactivity disorder |
| Authors: | Takahashi, Michihiro Browse this author | | Takita, Yasushi Browse this author | | Goto, Taro Browse this author | | Ichikawa, Hironobu Browse this author | | Saito, Kazuhiko Browse this author | | Matsumoto, Hideo Browse this author | | Tanaka, Yasuo Browse this author |
| Keywords: | atomoxetine | | attention-deficit/hyperactivity disorder | | Japanese adult | | safety | | tolerability |
| Issue Date: | Feb-2011 |
| Publisher: | Blackwell Publishing |
| Journal Title: | Psychiatry and Clinical Neurosciences |
| Volume: | 65 |
| Issue: | 1 |
| Start Page: | 55 |
| End Page: | 63 |
| Publisher DOI: | 10.1111/j.1440-1819.2010.02159.x |
| Abstract: | Aims: The main purpose of this first atomoxetine study in Japanese adults with Attention-Deficit/Hyperactivity Disorder (ADHD) was to investigate the tolerability of an 8 week treatment regimen. Methods: This was an open-label, dose escalation study conducted in 45 Japanese patients aged at least 18 years with DSM-IV-defined ADHD. Patients received atomoxetine orally for 8 weeks. Atomoxetine administration was started at 40 mg/day (7 days), and subsequently increased to a maximum dose of 120 mg/day. Tolerability was assessed by discontinuation rate due to adverse events. Adverse events, laboratory tests, vital signs and electrocardiograms were collected. In addition, ADHD symptoms were assessed by using the Japanese version of the Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) scores. Results: 39 patients completed the study period. Atomoxetine was well tolerated with a 6.7% (3/45) discontinuation rate due to nausea, malaise and anorexia. The most commonly reported adverse events were nausea, nasopharyngitis and headache; there were no unexpected safety concerns. No deaths or serious adverse events were reported. Mean CAARS-Inv:SV-J total ADHD symptom scores decreased in a time-dependent manner; the mean change from baseline to endpoint was -15.0 (P < 0.001). Conclusions: This study showed that atomoxetine was well tolerated in these patients and suggested that atomoxetine at a maximum dose of 120 mg/day would be safe in Japanese ADHD patients. |
| Rights: | The definitive version is available at www.wileyonlinelibrary.com |
| Type: | article (author version) |
| URI: | http://hdl.handle.net/2115/48166 |
| Appears in Collections: | 教育学院・教育学研究院 (Graduate School of Education / Faculty of Education) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)
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Submitter: 田中 康雄
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