RecruitingPhase 2NCT07316088
Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms
Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms in a Randomized Controlled Trial (RCT)
Sponsor
Oui Therapeutics, Inc.
Enrollment
40 participants
Start Date
Dec 9, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria7
- 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
Interventions
DEVICEOTX-601 Digital Therapeutic
Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD
DEVICEOTX-003 Comparator app
Comparator designed to match interface of intervention while providing no active treatment.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07316088
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