Plain-English translation of NCT07316088 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our PTSD research guide →Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.
This trial is testing whether OTX-601, a prescription digital app designed specifically for post-traumatic stress disorder (PTSD), can help reduce your trauma-related symptoms more effectively than a standard app interface. You would be randomly assigned to use either the active treatment app or a comparison app that looks similar but provides no active PTSD treatment. The study will measure your symptoms before and after 7 weeks of use.
Many people with PTSD don't have access to or can't complete traditional in-person therapy due to time, cost, or other barriers. This medication aims to deliver proven PTSD treatment methods through a smartphone app so it's more accessible and convenient for people who need help.
You would download and use your assigned app on your smartphone over 7 weeks. The app guides you through evidence-based techniques to help reduce PTSD symptoms, such as exercises that help you process traumatic memories and manage anxiety. You'll complete questionnaires at the beginning and end of the study to measure whether your symptoms have improved, and researchers will check in with you to track your progress.
AI-generated summary from trial data · Jul 21, 2026 · Not medical advice
United States
Phase
Testing effectiveness
Sponsor
Oui Therapeutics, Inc.
Collaborators
National Institute of Mental Health (NIMH), Florida State University
Enrollment target
~40 participants
Started
December 2025
Primary completion
July 2026
Age range
18 Years and older
Last updated on clinicaltrials.gov in July 2026.