The Department of Psychiatry is conducting a series of trials studying clinical interventions and their effectiveness.
1. Riluzole Augmentation for Treatment-Resistant PTSD
The double-blinded, multi-site Riluzole Augmentation study enrolled 70 participants with complicated combat-related PTSD to determine efficacy in treating depressive and anxiety symptoms and impact on quality of life.
Riluzole modulates the activity of glutamate, a highly prevalent neurotransmitter in the brain. Preclinical research suggests riluzole has a neuroprotective effect and may help reverse damage to brain regions where excitotoxicity due to excess glutamate activity is believed to contribute to PTSD symptoms.
The study also seeks to identify magnetic resonance spectroscopy concentrations of neurotransmitters and related chemicals in specific brain regions associated with PTSD before and after treatment as a potential biomarker of illness and treatment response. This study completed enrollment in November 2017 and is in data analysis and preparation for publication.
2. Enhancing Fear Extinction via Angiotensin Type 1 Receptor Inhibition: A Randomized Controlled Trial in Posttraumatic Stress Disorder
The Department is collaborating with the University of California San Diego to test the efficacy of losartan's as monotherapy for PTSD.
Losartan is an angiotensin receptor blocker currently FDA approved for treatment of hypertension. Preclinical investigations suggest losartan enhances fear extinction in animal models through as yet uncharacterized modifications to the angiotensin system in the central nervous system. Epidemiologic data from a large cross-sectional study revealed lower rates of PTSD in trauma patients treated with angiotensin receptor blockers.
An additional aim of the study is to examine the influence of variations in the angiotensin converting enzyme gene as a marker of response. Study is multi-site with study participants from Massachusetts General Hospital, McLean Hospital, New York University, and George Washington University. This study will close to enrollment in September 2019.
3. Pilot Trial of Nightmare Deconstruction and Reprocessing, a Novel Treatment for PTSD-Related Nightmares and Insomnia
The Department is partnering with Naval Hospital Camp Pendleton to test an exposure-based psychotherapy for PTSD-related nightmares.
Nightmare Deconstruction and Reprocessing (NDR) has been adapted for treating trauma-related nightmares from Clara Hill's 3-stage cognitive experiential dream model. Study objectives are to evaluate the feasibility and tolerability of NDR for treating PTSD nightmares and insomnia in military Service members and veterans; compare changes in symptoms to changes in genetic and inflammatory markers and physiologic data; and determine the research utility of a wristband device used to collect physiologic data. This study began enrollment in 2019.