By Staff Reports
(DGIwire) – Millions of Americans suffer winter doldrums. Add posttraumatic stress disorder (PTSD) to the mix and the “season to be jolly” can become a living nightmare. Among those facing this issue are military veterans; between 11 to 20 percent of those who served in Operations Iraqi Freedom and Enduring Freedom have PTSD in a given year, according to Military.com.
However, help is available. As Military.com notes, responders and staff at the Veterans Crisis Line at the Department of Veterans Affairs are available at all times, including the holiday season. And the Department of Defense Centers of Excellence for Psychological Health & Traumatic Brain Injury has published tips that can help those with PTSD better manage holiday stress, ranging from simplifying holiday plans to enlisting help from friends and family. There are other options for veterans year-round, of course—such as enlisting in clinical trials designed to test potentially improved PTSD treatments.
“The holidays can be a stressful time for everyone—and those with PTSD and their families can find it an especially challenging time,” says Seth Lederman, MD, the CEO of Tonix Pharmaceuticals, which is developing innovative pharmaceutical and biological products to address public health challenges, with its lead program focusing on PTSD. “Our ongoing clinical research in PTSD is designed to investigate the potential clinical benefit of our investigational new drug, a novel treatment approach for military-PTSD.”
The good news, however, for those with PTSD is that researchers are continuing to make progress in finding treatment options. As such, those who were in the military and think they may be affected by PTSD may consider speaking with their doctor about clinical research studies that are enrolling. For example, the HONOR study is a Phase 3 clinical research study sponsored by Tonix Pharmaceuticals that is investigating a new drug as a potential treatment for PTSD. At approximately 45 sites across the U.S., about 550 military-related PTSD participants will receive either the investigational new drug*, a sublingual (under the tongue) formulation of cyclobenzaprine, or placebo sublingual tablets, taken once-daily at bedtime. Based on the encouraging results in an earlier study with this drug in a population with military-related PTSD, the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to Tonix’s investigational new drug for the treatment of PTSD. FDA is committed to accelerating the development and approval of a Breakthrough Therapy that offers potential improvement over existing treatments for a serious disease.
What are the next steps for interested veterans? To see if a veteran is pre-qualified to participate in this research study, they should access the study website for this ongoing research study, TheHONORStudy.com, and learn more about it at https://clinicaltrials.gov/ct2/show/NCT03062540. The HONOR study is open to veterans or those currently serving in any branch of the military or as a military contractor.
The study is being conducted at a time when there are currently no satisfactory approved drug treatments for military-related PTSD. The investigational new drug used in the HONOR study represents a new approach to treating the condition. While symptoms of PTSD may improve or worsen while taking part in this research study, participation will provide information about the study drug, a new approach to treating PTSD that might benefit others with the condition in the future.
It is also important to note that there are steps taken to ensure the privacy of participants in this research study. To protect the participants’ identities and confidential medical information, the study organizers have obtained a Certificate of Confidentiality from the U.S. Department of Health & Human Services to ensure participants’ identities are shielded from all persons not connected with this clinical research project. The holder of this Certificate of Confidentiality may not be compelled in any Federal, state, or local civil, criminal, administrative, legislative or other proceedings to identify the research participants.
“Veterans with PTSD should be aware that studies like these are dedicated to helping those suffering from the horrendous impact of severely traumatic experiences—not just at holiday time but year-round,” adds Dr. Lederman.
*This investigational new drug has not been approved for any indication.