Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder (PTSD)
Status:
Terminated
Trial end date:
2008-12-11
Target enrollment:
Participant gender:
Summary
This is a single-blind, placebo-controlled, parallel group study to evaluate the efficacy of
BRL29060A (paroxetine hydrochloride hydrate, hereafter paroxetine) administered orally over
the dose range of 20 mg to 50 mg once daily after supper for 12 weeks in Japanese patients
with posttraumatic stress disorder (PTSD) as assessed by the change from baseline in CAPS-SX
total score. Also the effect of paroxetine on regional cerebral blood flow (rCBF) induced by
subthreshold emotional arousing (or symptom stimulating) tasks will be determined using
functional magnetic resonance imaging (fMRI) for exploratory assessment of the correlation
between the change in rCBF and the efficacy.
The sample size is 30 subjects. The study period consists of 4 weeks of run-in phase, 12
weeks of treatment phase, 0-3 weeks of taper phase and follow-up examination at 2 weeks after
the last dose, for a total of 18-21 weeks.
Subjects will visit the clinic at the start of run-in phase, Week -2, the start of treatment
phase, Weeks 2, 4, 6, 8 and 12 of treatment, and follow-up examination.