Clinical evaluation of paroxetine in post-traumatic stress disorder (PTSD): 52-week, non-comparative open-label study for clinical use experience.
OBJECTIVE
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.


CONCLUSIONS
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.
Kim
Yoshiharu
Y
National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, Japan.
Asukai
Nozomu
N
Konishi
Takako
T
Kato
Hiroshi
H
Hirotsune
Hideto
H
Maeda
Masaharu
M
Inoue
Hirotaka
H
Narita
Hiroyasu
H
Iwasaki
Masaru
M
D000328:Adult; D016000:Cluster Analysis; D005260:Female; D006801:Humans; D008297:Male; D017374:Paroxetine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013313:Stress Disorders, Post-Traumatic / Q000188:drug therapy* / Q000523:psychology; D016896:Treatment Outcome
D017374:Paroxetine; D017367:Selective Serotonin Reuptake Inhibitors