Clinical Trial: Quetiapine Augmentation for Treatment-resistant PTSD
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Placebo-controlled Trial of Adjunctive Quetiapine for Refractory PTSD
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 Summary:
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.
Sponsor: VA Office of Research and Development
Current Primary Outcome: Change in Clinician-Administered PTSD Scale for DSM-IV Total Score. [ Time Frame: From baseline (week 8) to endpoint (week 16 or termination) ]
Original Primary Outcome: Total CAPS change score from baseline to endpoint.
Current Secondary Outcome: PANSS,HAMD,CGI,DTS, PSQI,PSQI-A, Dream/Sleep Diary,Q-LES-Q,SDS,ASEX,AIMS, BAS, SAS [ Time Frame: Baseline to endpoint change scores ]
Original Secondary Outcome: Baseline to endpoint change scores in PANSS,HAMD,CGI,DTS, PSQI,PSQI-A, Dream/Sleep Diary,Q-LES-Q,SDS,ASEX,AIMS, BAS, SAS
Information By: VA Office of Research and Development
Dates:
Date Received: February 13, 2006
Date Started: January 2006
Date Completion:
Last Updated: June 27, 2014
Last Verified: June 2014