OTX-601 digital therapeutic to reduce PTSD symptoms
Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms in a Randomized Controlled Trial (RCT)
This trial will try a smartphone-based app called OTX-601 to see if it reduces PTSD symptoms in adults compared with a comparator app over seven weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oui Therapeutics, Inc. Industry-sponsored |
| Locations | 1 site (Tallahassee, Florida) |
| Trial ID | NCT07316088 on ClinicalTrials.gov |
What this trial studies
This Phase 2 randomized controlled trial compares the OTX-601 digital therapeutic app to a comparator app (OTX-003) in adults with diagnosed PTSD. Participants must have elevated anxiety sensitivity (ASI-3 > 24) and clinically significant PTSD symptoms (PCL-5 > 30), speak English, and have an internet-connected smartphone. The primary outcome is change in PTSD symptoms from baseline to seven weeks, using standard symptom measures. The protocol excludes people with active psychosis, acute intoxication at baseline, medical conditions preventing completion of interoceptive exposure exercises, or enrollment in other treatment research.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults with a formal PTSD diagnosis who have ASI-3 scores above 24, PCL-5 scores above 30, and access to an internet-connected smartphone.
Not a fit: Patients unlikely to benefit include those without PTSD or with low ASI-3 or PCL-5 scores, people with active psychosis or acute intoxication, those medically unable to do interoceptive exercises, non-English speakers, or those without a smartphone.
Why it matters
Potential benefit: If effective, this could provide a scalable, non-drug smartphone option that reduces PTSD symptoms within weeks.
How similar studies have performed: Previous digital interventions and interoceptive exposure approaches have shown promising early results for PTSD symptoms, but fully powered randomized trials remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Posttraumatic stress disorder (PTSD) diagnosis * Anxiety Sensitivity Index 3 (ASI-3) scores above 24 * PTSD Checklist for DSM-V (PCL-5) scores above 30 * Understands and speaks English * Access to a smartphone that is connected to the internet Exclusion Criteria: * Score of 24 or lower on the ASI-3 * Score of 30 and below on the PCL-5 * No PTSD diagnosis * Active psychosis * Acute intoxication during study baseline * Enrolled in another treatment research study * Medical illness that would prevent the completion of interoceptive exposure exercises
Where this trial is running
Tallahassee, Florida
- Florida State University — Tallahassee, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Brian Keenaghan
- Email: brian@ouitherapeutics.com
- Phone: 203-200-0482
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.