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

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

Recruiting
18 years and older
All
Phase 2
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Overview

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

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.

Eligibility

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 details
    PTSD
    Post Traumatic Stress Disorder

NCT07316088

Oui Therapeutics, Inc.

1 February 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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