Clinical evaluation of paroxetine in post‐traumatic stress disorder (PTSD): 52‐week,non‐comparative open‐label study for clinical use experience |
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Authors: | Yoshiharu Kim md phd Nozomu Asukai md phd Takako Konishi md phd Hiroshi Kato md phd Hideto Hirotsune md Masaharu Maeda md phd Hirotaka Inoue phd Hiroyasu Narita phd Masaru Iwasaki md phd |
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Affiliation: | 1. National Institute of Mental Health, National Center of Neurology and Psychiatry,;2. Division of Social Psychiatry, Tokyo Institute of Psychiatry,;3. Faculty of Human Science, Musashino University, Tokyo,;4. Hyogo Institute for Traumatic Stress, Hyogo,;5. Department of Neuropsychiatry and Psychosomatic Medicine, National Hospital Organization Osaka National Hospital, Osaka,;6. Department of Neuropsychiatry, Kurume University of Medicine, Kitakyushu, and;7. Development and Medical Affairs Division, GlaxoSmithKline, Tokyo, Japan |
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Abstract: | Aim: The present study was a 52‐week, non‐comparative, open‐label study of flexible dose paroxetine (20–40 mg) in 52 Japanese post‐traumatic stress disorder (PTSD) patients in order to obtain clinical experience regarding efficacy and safety in regular clinical practice. Methods: Efficacy was measured using the Clinician‐Administered PTSD Scale One Week Symptom Status Version (CAPS‐SX). Results: The mean change from baseline in CAPS‐SX total score was ?19.1, ?22.8 and ?32.3 at weeks 4, 12 and 52, respectively, and that in the Clinical Global Impression (CGI) Severity of Illness score was ?1.1 at week 12 and ?1.7 at week 52. A total of 46.9% were CGI responders at week 12, while 67.3% were improved on the CGI at week 52. Of 52 subjects who entered into the drug treatment, 25 completed the study. Only one patient withdrew from the study due to lack of efficacy. In patients who were rated as ‘moderately ill’ or less at baseline, the proportion of CGI responders at end‐point was higher at a dose of 20 mg/day than at higher doses, whereas in patients rated as ‘markedly ill’ or more, it was higher at 30 and 40 mg/day, suggesting that severely ill patients could benefit from higher doses. Conclusion: Paroxetine appeared generally tolerated in short‐ and long‐term use, and the safety profile in this study was consistent with international trials and other Japanese populations (i.e. patients suffering from depression, panic disorder or obsessive–compulsive disorder). Although the study was not conducted in double‐blind fashion, the current findings suggest that paroxetine may contribute to clinically meaningful improvement that is maintained during long‐term use and is generally well tolerated. |
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Keywords: | Japan paroxetine posttraumatic stress disorder (PTSD) |
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