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NCT Number: NCT07316088

Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

PTSD Mental Disorders Post Traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Florida State University

Tallahassee, Florida, 32306, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OTX-601 Digital Therapeutic

Device

Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD

OTX-003 Comparator app

Device

Comparator designed to match interface of intervention while providing no active treatment.

Primary outcomes

  1. 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

  1. Change in PTSD symptoms at weeks 15 and 27

    Time frame: Week 15, Week 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.

  2. Change in Anxiety Sensitivity at weeks 7, 15, and 27

    Time frame: Week 7, Week 15, Week 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.

  3. Change in Generalized Anxiety Disorder at weeks 7, 15, and 27

    Time frame: Week 7, Week 15, Week 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.

  4. Change in well-being at weeks 7, 15, and 27

    Time frame: Week 7, Week 15, Week 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.

  5. Anxiety sensitivity as a mediator of treatment effects on PTSD symptoms at week 3

    Time frame: 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.

  6. App usability at week 3

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Oui Therapeutics, Inc.

Industry

Collaborators

  • Florida State University
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms in a Randomized Controlled Trial (RCT)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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