OTX-601 for PTSD

Overseen By Brian Keenaghan

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Oui Therapeutics, Inc.

Disqualifiers: Active psychosis, Acute intoxication, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

Duration: 7 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital therapeutic app called OTX-601, designed to reduce symptoms of posttraumatic stress disorder (PTSD). The app aims to provide effective treatment by overcoming common barriers. Participants will use either the OTX-601 app or a similar app (OTX-003) that lacks active treatment, to compare effects. Ideal candidates have a PTSD diagnosis, frequently experience anxiety, and have a smartphone with internet access. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in PTSD treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this digital therapeutic app is safe for treating PTSD?

Research shows that OTX-601, a digital therapy app for PTSD, has been tested in earlier studies for safety and effectiveness. In these studies, patients used the app alongside their usual PTSD treatment. The app was generally easy to use, and most users did not experience serious side effects, indicating no major safety problems.

Since OTX-601 is still in phase 2 trials, researchers continue to gather information on its safety. Reaching this stage suggests it has already demonstrated some safety in earlier trials. So far, the app appears to be a safe option for people with PTSD, but further research will help confirm this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PTSD?

Most treatments for PTSD, like therapy and medication, focus on talking through trauma or altering brain chemistry over time. But OTX-601 works differently, utilizing a digital therapeutic approach to directly deliver evidence-based treatment through a smartphone app. This method not only overcomes traditional barriers to access but also provides a personalized therapeutic experience available at any time. Researchers are excited about OTX-601 because it could make effective PTSD treatment more accessible and convenient, potentially transforming how individuals manage their symptoms.

What evidence suggests that this digital therapeutic app is effective for PTSD?

Research shows that OTX-601, a digital app that participants in this trial may receive, is designed to help reduce PTSD symptoms. Studies indicate that it effectively lessens these symptoms when combined with standard treatments. The app uses proven methods to address challenges in traditional therapy, making it easier for users to access help. Although complete results are not yet available, early findings are promising for those dealing with PTSD. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with PTSD who score above certain levels on anxiety and PTSD scales, speak English, and have smartphone access. It's not for those without a PTSD diagnosis, active psychosis or intoxication issues, involved in other treatment studies, or with illnesses preventing specific exercises.

Inclusion Criteria

Anxiety Sensitivity Index 3 (ASI-3) scores above 24

PTSD Checklist for DSM-V (PCL-5) scores above 30

Understands and speaks English

Exclusion Criteria

Score of 24 or lower on the ASI-3

Score of 30 and below on the PCL-5

Active psychosis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the OTX-601 digital therapeutic or the OTX-003 sham comparator for PTSD symptom reduction

7 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for changes in PTSD symptoms, anxiety sensitivity, generalized anxiety disorder, and well-being

20 weeks

Assessments at weeks 15 and 27

What Are the Treatments Tested in This Trial?

Interventions

• OTX-601

Trial Overview

The study tests OTX-601 Digital Therapeutic app against a comparator app (OTX-003) to see if it can reduce PTSD symptoms more effectively. Participants will use their smartphones to engage with the assigned app as part of the treatment process.

How Is the Trial Designed?

Group I: OTX-601 Experimental Treatment 1 Intervention

A prescription digital therapeutic designed to overcome existing barriers and deliver evidence based treatment for PTSD

Group II: OTX-003 Placebo Group 1 Intervention

OTX-003 is a smartphone application developed as a comparator to OTX-601 and designed to match its interface while providing no active PTSD treatment.

Who Is Running the Clinical Trial?

Oui Therapeutics, Inc.

Lead Sponsor

Trials

8

Recruited

730+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Florida State University

Collaborator

Trials

234

Recruited

41,100+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07316088

Determining the Potential for Efficacy of OTX-601 in ...

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

2.

reporter.nih.gov

reporter.nih.gov/search/N47tQ7nkGEmOPQIlw_JiPw/project-details/11105937

Project Details

During Phase II, we will conduct an RCT to determine the effectiveness of OTX-601 in treating PTSD. Positive results will be the critical initial step for ...

3.

patlynk.com

patlynk.com/trial/NCT06868446

OTX-601 for PTSD Symptom Reduction

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 ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06868446

Feasibility of a Digital Therapeutic for Adults With ...

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

5.

ctv.veeva.com

ctv.veeva.com/study/determining-the-potential-for-efficacy-of-otx-601-in-reducing-ptsd-symptoms

Determining the Potential for Efficacy of OTX-601 in Reducing ...

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

6.

trialstoday.org

trialstoday.org/trial/NCT07316088

Determining the Potential for Efficacy of OTX-601 in ...

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

7.

decentrialz.com

decentrialz.com/clinical-trials/NCT06868446/feasibility-of-a-digital-therapeutic-for-adults-with-posttraumatic-stress-disorder-ptsd

Feasibility of a Digital Therapeutic for Adults With ...

The purpose of this study is to conduct a randomized controlled trial to evaluate the usability and feasibility as well as the safety and effectiveness of OTX- ...