Currently, there are no tools to predict treatment outcomes for PTSD. Trauma-focused psychotherapies are the most evidence-based treatments for PTSD; however, only a minority of individual with PTSD pursue this type of treatment even though not seeking psychotherapy lowers the likelihood of recovery. Knowledge that patients would likely respond to psychotherapy would encourage them to pursue treatment. Developing a test that predicts a good outcome will encourage implementing PTSD psychotherapy skills in the community, allowing more patients to seek these treatments.
Despite many years of pioneering work studying the brain’s behavior and how it functions in individuals with PTSD, the field of psychiatry lacks objective measures for understanding the many different biological effects of PTSD (i.e., sleepless nights, spontaneous moments of panic, faltering memory, poor cognition, or erratic moods). As a result, there are no reliable ways to determine who will benefit from which treatment. Moreover, PTSD is incredibly heterogeneous; groups of symptoms, which help physicians diagnose PTSD, differ widely depending on which diagnostic test is used.
Establishing objective metrics to identify distinct, biological biomarkers of PTSD could provide the basis for targeted treatment and development of novel therapeutics. Additionally, grouping patients by expected response to psychotherapy can also support the use of these biomarkers as companion diagnostics in developing and testing new interventions.
CVB has teamed up with Stanford University to study clinical biomarkers and identify brain activity patterns – or neural signatures – in PTSD to help match patients to the most effective available treatment.
Amit Etkin, MD, PhD, Professor of Psychiatry and Behavioral Sciences at Stanford University, conducted a study to evaluate if PTSD ‘markers’ can help inform effective treatment decisions. By exploring both neural signatures of PTSD and differences in memory function using function MRI (fMRI) and cognitive tests, this study identified a novel method for disentangling the heterogeneity (variations) of PTSD by characterizing patient sub-groups. These findings provide objective evidence for predicting a patient’s response to treatment and will promote the transition from a subjective diagnosis of PTSD based on symptom report, to an objective diagnosis based on underlying biological causes. Findings from this study were recently published in the journal, Science Translational Medicine.
The BEST-PTSD study includes Veterans with PTSD who will receive either on-going cognitive processing therapy (CPT) or prolonged exposure (PE) therapy. The study will also include a control group of Veterans without PTSD to establish “normative” responses for brain and behavioral assessments. Further, BEST seeks to translate earlier findings using functional MRI (fMRI) to a more widely accessible form of brain scanning, EEG.
The Study is set to complete at the end of 2019. If successful, this brain biomarker will be the first of its kind for PTSD and may help accelerate the pace of discovery of effective treatments, leading researchers to a path for personalized medicine approaches and matching patients with the best interventions more quickly.
The next steps for this program will be to develop these brain biomarkers as diagnostics tests through the FDA Center for Devices and Radiological Health (CDRH) devices program.
Impact to Veterans
The Impact for Veterans is that a Response Diagnostic Test would be a Clinical Decisions Support Tool for their doctor to use in guiding the best treatment options for them.
“Our goal is to create a brain signature specific to an individual and then tailor treatment accordingly,” says Dr. Etkin. “Ultimately, we hope to have a clinic-ready tool that will dramatically change how we care for patients with post-traumatic stress.”
“Post-traumatic stress presents in patients in myriad of ways, which underscores the need for individualizing treatment,” says Magali Haas, MD, PhD, CEO & President of Cohen Veterans Bioscience. “Our collaboration with the talented team at Stanford will lead us one step closer to understanding the mechanisms underlying PTSD in specific individuals, which is critical if we are to develop diagnostic tests that can provide accurate diagnoses, new treatments, and tools to measure the effectiveness of a given treatment.”