Condition: Acute Stress Reaction · Acute Stress Disorder · Neurocognitive Function · Sponsor: University of North Carolina, Chapel Hill
This study will examine the safety and efficacy of TNX-102 SL to reduce ASR symptoms and behavioral changes among patients presenting to the emergency department (ED) after motor vehicle collision (MVC). Specifically, the investigators will perform the Optimizing Acute Stress reaction Interventions with TNX-102 SL (OASIS) Trial, a double-blind placebo-controlled randomized clinical trial (RCT) to determine if TNX-102 SL initiated in the ED in the hours after MVC to high risk individuals, treats/reduces acute stress reaction (ASR)/acute stress disorder (ASD) symptoms (primary outcome), improves neurocognitive function, and prevents/reduces posttraumatic stress (PTS) symptoms (secondary outcomes) long term. 180 participants will be randomized, receive study drug in ED and be discharged with a 2-week drug supply. Prior to initial dose of study drug administration, and during the hours, days, and weeks after participants will receive serial longitudinal assessments of psychological and somatic symptoms, neurocognitive function, and adverse events.
This description comes directly from the study's public registry record.
Romina Soudavari · 9843195030 · romina_soudavari@med.unc.edu
Always discuss trial participation with your own doctor first.
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| Indiana University | Indianapolis, Indiana, United States | Recruiting |
| University of Kansas Medical Center | Kansas City, Kansas, United States | Recruiting |
| Washington University in St. Louis | St Louis, Missouri, United States | Recruiting |
| Cooper University Health System | Camden, New Jersey, United States | Recruiting |
| The Ohio State University | Columbus, Ohio, United States | Recruiting |
| Rhode Island Hospital | Providence, Rhode Island, United States | Recruiting |
| The Miriam Hospital | Providence, Rhode Island, United States | Recruiting |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas, United States | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06636786