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

NCT07316088 | Recruiting Phase 2

• 2 other identifiers: 2024-Oui-002-Study2R44MH136888
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

PTSD; Post Traumatic Stress Disorder

Keywords

PTSD

Outcome Measures

Primary Outcomes (1)

• Change in PTSD symptoms between baseline and week 7

  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.

  Baseline, Week 7

Secondary Outcomes (6)

• Change in PTSD symptoms at weeks 15 and 27

  Week 15, Week 27

• Change in Anxiety Sensitivity at weeks 7, 15, and 27

  Week 7, Week 15, Week 27

• Change in Generalized Anxiety Disorder at weeks 7, 15, and 27

  Week 7, Week 15, Week 27

• Change in well-being at weeks 7, 15, and 27

  Week 7, Week 15, Week 27

• Anxiety sensitivity as a mediator of treatment effects on PTSD symptoms at week 3

  Week 3

Study Arms (2)

OTX-601

EXPERIMENTAL

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

Device: OTX-601 Digital Therapeutic

OTX-003

SHAM COMPARATOR

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.

Device: OTX-003 Comparator app

Interventions

OTX-003 Comparator app DEVICE

Comparator designed to match interface of intervention while providing no active treatment.

OTX-003

OTX-601 Digital Therapeutic DEVICE

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

OTX-601

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oui Therapeutics, Inc.: lead
• National Institute of Mental Health (NIMH): collaborator
• Florida State University: collaborator

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Brian Keenaghan

CONTACT

203-200-0482; brian@ouitherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 5, 2026
• Study Start: December 9, 2025
• Primary Completion: March 20, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

US (1)