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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00557622 |
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.
Condition | Intervention | Phase |
---|---|---|
Posttraumatic Stress Disorder (PTSD) |
Drug: BRL29060A |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder (PTSD) - A Placebo-Controlled, Single-Blind Comparative Study - |
Estimated Enrollment: | 30 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | May 2008 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 20 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects whose drug compliance rate for Drug 1 (Run-in Phase placebo) is <80% between Week -4 and Week 0;
Subjects whose CAPS-SX total score of the standard B, C, and D at Week 0 varied by 25% or more compared with those at Week -2
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Japan | |
GSK Investigational Site | Active, not recruiting |
Tokyo, Japan, 170-0002 | |
GSK Investigational Site | Withdrawn |
Hiroshima, Japan, 734-8551 | |
GSK Investigational Site | Recruiting |
Tokyo, Japan, 113-8602 | |
GSK Investigational Site | Withdrawn |
Tokyo, Japan, 156-8585 | |
GSK Investigational Site | Withdrawn |
Tokyo, Japan, 113-8603 | |
GSK Investigational Site | Recruiting |
Tokyo, Japan, 114-0002 | |
GSK Investigational Site | Withdrawn |
Tokyo, Japan, 190-0014 | |
GSK Investigational Site | Active, not recruiting |
Tokyo, Japan, 162-0056 | |
GSK Investigational Site | Active, not recruiting |
Tokyo, Japan, 162-8666 | |
GSK Investigational Site | Withdrawn |
Tokyo, Japan, 187-8553 | |
GSK Investigational Site | Withdrawn |
Tokyo, Japan, 143-8541 | |
GSK Investigational Site | Recruiting |
Chiba, Japan, 272-0133 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | PIR109164 |
Study First Received: | November 12, 2007 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00557622 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Paroxetine PTSD (Posttraumatic Stress Disorder) CAPS fMRI |
Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress |
Paroxetine Serotonin Stress Disorders, Traumatic |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors |
Pharmacologic Actions Pathologic Processes Serotonin Agents Therapeutic Uses Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |