Ignite Creation Date:
2024-05-05 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00557622
Status:
TERMINATED
Last Update Posted:
2020-11-30
First Post:
2007-11-12
Brief Title:
Clinical Evaluation of BRL29060A Paroxetine Hydrochloride Hydrate in Posttraumatic Stress Disorder PTSD
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Clinical Evaluation of BRL29060A Paroxetine Hydrochloride Hydrate in Posttraumatic Stress Disorder PTSD - A Placebo-controlled Single-Blind Comparative Study -
Status:
TERMINATED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
difficulty in achieving target enrollment numbers
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None