Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292370
Status:
COMPLETED
Last Update Posted:
2019-10-16
First Post:
2006-02-13
Brief Title:
Quetiapine Augmentation for Treatment-resistant PTSD
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
A Placebo-controlled Trial of Adjunctive Quetiapine for Refractory PTSD
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the response of veterans with PTSD without an optimal response to paroxetine to quetiapine augmentation versus placebo
Detailed Description:
This is a two-site study designed to evaluate the efficacy and safety of quetiapine augmentation of paroxetine treatment in veterans with PTSD who have failed to respond to paroxetine treatment
In Phase I eligible patients will take open-label paroxetine up to 60 mg daily for 8 weeks Patients who are refractory less than 30 reduction in CAPS scores or a minimum CAPS score of 50 at week 8 and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for the second phase In Phase II patients will continue taking open-label paroxetine and will be randomized to the addition of quetiapine up to 800 mg daily or placebo for 8 weeks in a double-blind fashion
In Phase I eligible patients will take open-label paroxetine up to 60 mg daily for 8 weeks Patients who are refractory less than 30 reduction in CAPS scores or a minimum CAPS score of 50 at week 8 and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for the second phase In Phase II patients will continue taking open-label paroxetine and will be randomized to the addition of quetiapine up to 800 mg daily or placebo for 8 weeks in a double-blind fashion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None