Stress Disorders, Post-Traumatic Clinical Trial
Official title:
A Placebo-controlled Trial of Adjunctive Quetiapine for Refractory PTSD
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.
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.
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