Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms in a Randomized Controlled Trial (RCT)
Oui Therapeutics, Inc.
Summary
This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.
Description
The purpose of this study is to conduct a randomized controlled trial to evaluate the efficacy of OTX-601 (intervention) compared to OTX-003 (comparator) in reducing PTSD symptoms from baseline to 7 weeks.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
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.
Location
- Florida State UniversityTallahassee, Florida