Quetiapine augmentation of prolonged exposure therapy in veterans with PTSD and a history of mild traumatic brain injury: design and methodology of a pilot study

Abstract

Background Selective serotonergic reuptake inhibitors (SSRIs) are first-line pharmacologic treatments for patients with posttraumatic stress disorder (PTSD), but must be given over extended period of time before the onset of action. The use of SSRIs in PTSD patients with mild traumatic brain injury (mTBI) is problematic since SSRIs could exacerbate post-concussion syndrome (PCS) symptoms. VA/DOD guidelines identify trauma-focused psychotherapy as the best evidence-based treatment for PTSD, but overall effectiveness is limited by reduced levels of patient engagement and retention. A previous study from this research group suggested that quetiapine monotherapy, but not risperidone or valproate, could increase engagement in trauma-focused psychotherapy. Methods We report the study protocol of a pilot study funded under the South-Central Mental Illness Research, Education, and Clinical Center pilot study program from the U.S. Department of Veterans Affairs. This randomized, open-label study was designed to evaluate the feasibility of completing a randomized trial of quetiapine vs. treatment as usual to promote patient engagement in PTSD patients with a history of mTBI. Discussion We expect that the success of this ongoing study should provide us with the preliminary data necessary to design a full-scale randomized trial. Positive efficacy results in a full- scale trial should inform new VA guidelines for clinical practice by showing that quetiapine-related improvements in patient engagement and retention may be the most effective approach to assure that VA resources achieve the best possible outcome for veterans. Trial registration NCT04280965.

Pushing the frontiers of military medical excellence: updates, progress and future needs

“…To tackle the negative effects of sleep deprivation or poor sleep quality on the mental health well-being of soldiers, Harrison et al [23] studied the chronotype profile of U.S. sailors, and suggested aligning military schedules with endogenous circadian rhythms to optimise performance. On the other hand, Baig et al [24] found that quetiapine monotherapy can increase engagement in trauma-focused psychotherapy, given that fluoxetine, the alternative pharmacologic treatment for PTSD, has an extended onset of action and can exacerbate post-concussion syndrome in mild TBI. Despite military psychiatry being an established field, there leaves much more knowledge to be discovered in this ever-evolving specialty, which is only made possible with continued research.…”

Military traumatic brain injury: a challenge straddling neurology and psychiatry

“…Pharmacological and physical therapies for TBI remain a research focus. A 2020 study suggested that quetiapine augmentation of prolonged exposure therapy may be beneficial to veterans suffering from TBI and PTSD, but the effectiveness of the treatment has yet to be proven [139]. In a meta-analysis involving 7 randomized controlled trials testing the TBI-treating effect of erythropoietin (EPO), no statistically significant results were found in neurological function improvement and acute hospitalization rate reduction after 6 months; however, the EPO intervention group had a more significant survival benefit than the saline placebo group [140].…”