Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms in a Randomized Controlled Trial (RCT)
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Oui Therapeutics, Inc.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in PTSD symptoms between baseline and week 7
Study Overview
Brief Summary
This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- 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
Arms & Interventions
OTX-601
A prescription digital therapeutic designed to overcome existing barriers and deliver evidence based treatment for PTSD
Intervention: OTX-601 Digital Therapeutic (Device)
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.
Intervention: OTX-003 Comparator app (Device)
Outcomes
Primary Outcomes
Change in PTSD symptoms between baseline and week 7
Time Frame: Baseline, Week 7
Change in PTSD symptoms will be ascertained with the PTSD Checklist for DSM-V (PCL-5). The PCL-5 total score ranges from 0 to 80, with higher scores indicating more severe symptoms.
Secondary Outcomes
- Change in PTSD symptoms at weeks 15 and 27(Week 15, Week 27)
- Change in well-being at weeks 7, 15, and 27(Week 7, Week 15, Week 27)
- Change in Anxiety Sensitivity at weeks 7, 15, and 27(Week 7, Week 15, Week 27)
- Anxiety sensitivity as a mediator of treatment effects on PTSD symptoms at week 3(Week 3)
- Change in Generalized Anxiety Disorder at weeks 7, 15, and 27(Week 7, Week 15, Week 27)
- App usability at week 3(Week 3)