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OTX-601 for PTSD Symptom Reduction

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What is being tested

Digital Therapeutic (Version 1)

+ Treatment as Usual (TAU)
+ Digital Therapeutic (Version 2)
Device
Behavioral
Who is being recruted

Trauma and Stressor Related Disorders
+1

+ Mental Disorders
+ Stress Disorders, Post-Traumatic
Over 18 Years
See all eligibility criteria
How is the trial designed

Device Feasibility Study

Phase 1
Interventional
Study Start: June 2025
See protocol details

Summary

Principal SponsorOui Therapeutics, Inc.
Study ContactBrian Keenaghan
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: June 30, 2025Actual date on which the first participant was enrolled.

This study aims to explore the use and practicality of a treatment called OTX-601 for people with post-traumatic stress disorder (PTSD). The study seeks to understand how effective and safe two versions of OTX-601, when combined with treatment as usual (TAU), can be in lessening PTSD symptoms over a period of seven weeks. This research is significant as it seeks to improve the quality of life for those suffering from PTSD by potentially offering a new and effective treatment option. Participants in the study will be randomly assigned to receive either version 1 or version 2 of OTX-601, alongside their regular treatment. The study will closely monitor changes in PTSD symptoms from the start to the end of the seven-week period to evaluate the effectiveness of each version of the treatment. The study also looks at how easy and acceptable the treatment is for participants, ensuring it is a feasible option for real-world use. By assessing both safety and effectiveness, the study aims to provide valuable insights into how OTX-601 can best help those with PTSD.

Official TitleDosage, Feasibility, Acceptability and Usability of OTX-601 
NCT06868446
Principal SponsorOui Therapeutics, Inc.
Study ContactBrian Keenaghan
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
40 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Device Feasibility Study
These studies test whether a new medical device (like a tool or piece of equipment) is safe and practical to use. They're usually small and focus on how the device works rather than how well it treats a condition.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Trauma and Stressor Related Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
A prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD

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

Treatment as usual may include psychotherapy and/or pharmacological interventions.
Group II
Experimental
Increased dose of a prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD

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

Treatment as usual may include psychotherapy and/or pharmacological interventions.
Study Objectives
Primary Objectives

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.

App usability 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.
Secondary Objectives

Change in anxiety sensitivity level 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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 
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