OTX-601 for PTSD Symptom Reduction
Digital Therapeutic (Version 1)
+ Treatment as Usual (TAU)
+ Digital Therapeutic (Version 2)
Trauma and Stressor Related Disorders+1
+ Mental Disorders
+ Stress Disorders, Post-Traumatic
Device Feasibility Study
Summary
Study start date: June 30, 2025
Actual 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Device Feasibility Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives