Quetiapine Augmentation of Cognitive Processing Therapy in Veterans with Posttraumatic Stress Disorder. Design and Methodology of a Pilot Study

Abstract

BackgroundThe limited efficacy of first-line treatment of posttraumatic stress disorder (PTSD) with selective serotonergic reuptake inhibitors commonly leads to the use of multiple medications that still fail to achieve symptomatic remission. VA/DOD guidelines identify trauma-focused psychotherapies as the evidence-based treatment for PTSD, but overall effectiveness is limited by reduced levels of patient engagement. Cognitive processing therapy (CPT) is the most widely-used trauma-focused therapy in the VA system for Veterans with PTSD. Our previous results based on a case series suggested that quetiapine monotherapy, but not risperidone or valproate, could increase engagement in CPT, thereby improving clinical outcomes through direct medication effects and indirectly through greater engagement in CPT.Methods & ResultsWe report the study protocol of a pilot study. This randomized, double blind placebo-controlled study was designed to evaluate the feasibility, safety, and preliminary efficacy of completing a randomized trial of quetiapine vs. placebo as an adjunct to promote patient engagement in CPT treatment for PTSD.ConclusionsWe expect that the success of this ongoing study should provide us with the preliminary data necessary to design a full-scale randomized trial.Trial Registration:NCT04280965