By Staff Reports
(DGIwire) – Exposure to traumatic experiences has always been a part of the human condition. Accounts of what doctors now call post-traumatic stress disorder (PTSD) date back centuries. Research about veterans returning from combat has been critical to the establishment of the diagnosis—so the history of what is now known as PTSD often references the history of combat.
On its website, the National Center for PTSD traces this history along with doctors’ evolving understanding of its causes and symptoms. For example, what was referred to as “shell shock” in the wake of World War I—because it was seen as a reaction to the explosion of artillery shells—was first thought to result from hidden physical damage to the brain. Subsequently, what was referred to as “battle fatigue” or “combat stress reaction” in World War II—and later as PTSD in successive editions of the American Psychiatric Association’s Diagnostic and Statistical Manual—was seen to be much more subtle and widespread. No longer viewed as an anxiety disorder, the DSM-5 now classifies PTSD in a category labeled Trauma- and Stressor-Related Disorders.
“Our knowledge of PTSD has grown considerably over the past century but much remains to be learned about effective treatment,” says Seth Lederman, MD, the CEO of Tonix Pharmaceuticals, which is developing innovative pharmaceutical products to address public health challenges, with its lead program focusing on PTSD. “Our ongoing study in PTSD is designed to pinpoint how these treatments can impact veterans.”
Those who were in the military and think they may be affected by PTSD should consider speaking with their doctor about the latest clinical research study involving an investigational new drug as a potential treatment for PTSD, the HONOR study, a Phase 3 clinical research study sponsored by Tonix Pharmaceuticals. At approximately 35 sites across the U.S., about 550 military-related PTSD patients will receive either the investigational new drug, TNX-102 SL* or placebo sublingual tablets, once-daily at bedtime. Based on the encouraging results in an earlier study with TNX-102 SL in a population with military-related PTSD, the U.S. Food and Drug Administration recently granted Breakthrough Therapy designation to TNX-102 SL for the treatment of PTSD.
To protect the subjects’ 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 patients’ 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 subjects.
To see if you or someone you know is pre-qualified to participate in this research study, please access the study website for this ongoing research study, TheHonorStudy.com, and learn more about it at https://clinicaltrials.gov/show/NCT03062540. The HONOR study is open to veterans or those currently serving in any branch of the military or as a military contractor.
Currently there are 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 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.
* TNX-102 SL is an investigational new drug and has not been approved for any indication.