Seelos Therapeutics, Inc. announced that SLS-002 (intranasal racemic ketamine) has been selected for inclusion in an adaptive platform trial to evaluate treatments for post-traumatic stress disorder (PTSD) in active-duty service members and veterans. The trial is funded by the U.S. Department of Defense's (DOD) Defense Health Agency and led by the Warfighter Readiness, Performance, and Brain Health Project Management Office, part of the U.S. Army Medical Materiel Development Activity. The Department of Defense PTSD Adaptive Platform Trial (NCT05422612) is a Phase II randomized, double-blinded, placebo-controlled study that will evaluate the safety, tolerability, and efficacy of multiple pharmacotherapeutic interventions in active-duty service members, veterans with PTSD.

The trial will utilize an adaptive platform trial design randomizing participants among the multiple treatment cohorts selected for inclusion in the study and enable sharing of control participants to increase study efficiency. The design of the trial entails a 30-day screening period, a 12-week treatment period and a 4-week safety follow-up and will collect data to measure changes in PTSD symptom severity, as measured by the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) and other clinically relevant endpoints, including the incidence of new or worsening suicidal thoughts or behaviors, as measured by change in the Columbia Suicide Severity Rating Scale (C-SSRS) score. In addition, the trial will evaluate several biomarkers associated with PTSD and assessments of treatment safety and tolerability.

According to the U.S. department of Veterans Affairs, in 2020, about 13 million Americans had PTSD and 5% of the U.S. population suffers from PTSD in any given year. Active military service members and veterans are more likely to have PTSD (6% for male veterans versus 13% for female veterans) than civilians (6%) and the incidence of PTSD varies by military service era and has increased significantly for veterans of more recent conflicts. The incidence of veterans being diagnosed with PTSD at some point in their lives was 3% for veterans of World War II and the Korean War, 10% for the Vietnam War, 21% for thePers Gulf War (Desert Storm) and 29% for Operations Iraqi Freedom and Enduring Freedom.

Beyond war and combat, PTSD can be caused by exposure to any traumatic experience such as non-military violence or accidents, neglected, physical or sexual abuse, and natural disasters such as wildfires, floods, and earthquakes.