Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms
Purpose
This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.
Conditions
- PTSD
- Post Traumatic Stress Disorder
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental OTX-601 |
A prescription digital therapeutic designed to overcome existing barriers and deliver evidence based treatment for PTSD |
|
|
Sham Comparator OTX-003 |
OTX-003 is a smartphone application developed as a comparator to OTX-601 and designed to match its interface while providing no active PTSD treatment. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Oui Therapeutics, Inc.
Detailed 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.
