This was a 52-week, non-comparative, uncontrolled study of paroxetine in Japanese PTSD patients to obtain clinical experience regarding efficacy and safety. In this study, subjects received paroxetine 20mg-40mg once daily after an evening meal.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Subjects will take the treatment phase medication once daily after an evening meal. All subjects will be maintained at Dose Level II (20 mg/day) for the first 2 weeks. If a sufficient clinical response ("1. Very much improved" or "2. Much improved" based on the CGI Global Improvement) is achieved, the subject will continue on the same dose level. When the clinical response is not sufficient but the investigational product is well tolerated, the dose will be increased to Dose Level III (30 mg/day) and then to Dose Level IV (40 mg/day) at intervals of at least 2 weeks until a sufficient response is reached. Once a sufficient response is obtained, the treatment will be continued at that dose. The treatment phase will last for a total of 52 weeks. In those patients receiving Dose Level III or IV, dosage reductions to the next lowest level (Dose Level II or III) consequent to an adverse event are permitted. Dosage adjustment will be made at the discretion of the PI or Sub-PI
Change from baseline in the Clinician-Administered Posttraumatic Stress Disorder Scale One Week Symptom Status Version (CAPS-SX) total score
Time frame: 52 weeks
Proportion of responders based on the CGI Global Improvement
Time frame: 52 weeks
Change from baseline in the CAPS-SX re-experiencing cluster score
Time frame: 52 weeks
Change from baseline in the CAPS-SX avoidance/numbing cluster score
Time frame: 52 weeks
Change from baseline in the CAPS-SX hyperarousal cluster score
Time frame: 52 weeks
Change from baseline in the CGI Severity of Illness score
Time frame: 52 weeks
Adverse events (AEs), abnormal findings in each examination/test, and their details: Laboratory tests (hematology, clinical chemistry, electrolytes, urinalysis), Blood pressure, pulse rate, body weight
Time frame: 52 weeks
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