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)

This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.

Study Overview

• Status: Recruiting
• Conditions: PTSD; Post Traumatic Stress Disorder
• Intervention / Treatment: Device: OTX-601 Digital Therapeutic; Device: OTX-003 Comparator app

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Brian Keenaghan; Phone Number: 203-200-0482; Email: brian@ouitherapeutics.com

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Recruiting
      • Florida State University
      • Contact: Professor of Psychology; Phone Number: 850-645-8729; Email: cougle@psy.fsu.edu
      • Principal Investigator: Jesse Cougle, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OTX-601; A prescription digital therapeutic designed to overcome existing barriers and deliver evidence based treatment for PTSD	Device: OTX-601 Digital Therapeutic; 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.	Device: OTX-003 Comparator app; Comparator designed to match interface of intervention while providing no active treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PTSD symptoms between baseline and 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.	Baseline, Week 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PTSD symptoms at weeks 15 and 27	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.	Week 15, Week 27
Change in Anxiety Sensitivity at weeks 7, 15, and 27	Change in Anxiety Sensitivity will be measured using the Anxiety Sensitivity Index-3 (ASI-3). The ASI-3 total score ranges from 0 to 72 with a higher score indicating greater anxiety sensitivity.	Week 7, Week 15, Week 27
Change in Generalized Anxiety Disorder at weeks 7, 15, and 27	Change in Generalized Anxiety Disorder will be assessed with the Generalized Anxiety Disorder 7-item (GAD-7) assessment. GAD-7 total score for the seven items ranges from 0 to 21 where a score ranging from 0-4 indicates minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.	Week 7, Week 15, Week 27
Change in well-being at weeks 7, 15, and 27	Change in well-being will be assessed through the General Life Satisfaction Scale (GLSS). The GLSS total score ranges from 5-35 with higher scores indicating greater life satisfaction.	Week 7, Week 15, Week 27
Anxiety sensitivity as a mediator of treatment effects on PTSD symptoms at week 3	Anxiety sensitivity will be ascertained with the Anxiety Sensitivity Index-3 (ASI-3). The ASI-3 total score ranges from 0 to 72 with a higher score indicating greater anxiety sensitivity.	Week 3
App usability at week 3	App usability which will be ascertained with the System Usability Scale (SUS). The SUS provides a score from 0 to 100. An average SUS score equal to or greater than 68 is considered usable.	Week 3

Collaborators and Investigators

• Sponsor: Oui Therapeutics, Inc.
• Collaborators: National Institute of Mental Health (NIMH); Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2025
• Primary Completion (Estimated): March 20, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: December 31, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: PTSD
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2024-Oui-002-Study2; R44MH136888 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No