RecruitingPhase 2NCT07316088

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)


Sponsor

Oui Therapeutics, Inc.

Enrollment

40 participants

Start Date

Dec 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a digital tool called OTX-601 — a smartphone-based program — to see if it can help reduce symptoms of PTSD (post-traumatic stress disorder) by training people to become less sensitive to uncomfortable physical sensations (a technique called interoceptive exposure). **You may be eligible if...** - You have a diagnosis of PTSD - You scored above 24 on the Anxiety Sensitivity Index (ASI-3) - You scored above 30 on the PTSD Checklist (PCL-5) - You understand and speak English - You have a smartphone with internet access **You may NOT be eligible if...** - You scored 24 or below on the ASI-3 or 30 or below on the PCL-5 - You do not have a PTSD diagnosis - You have active psychosis - You were intoxicated during the baseline assessment - You are enrolled in another treatment research study - You have a medical condition that prevents you from doing physical breathing or body awareness exercises Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Florida State University

Tallahassee, Florida, United States

View Full Details on ClinicalTrials.gov

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NCT07316088


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