NCT06868446

Feasibility of a Digital Therapeutic for Adults With Posttraumatic Stress Disorder (PTSD)

Dosage, Feasibility, Acceptability and Usability of OTX-601

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Oui Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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-601 (version 1) + TAU compared to OTX-601 (version 2) + TAU in reducing PTSD symptoms from baseline to 7 weeks.

Conditions

• PTSD
• Post Traumatic Stress Disorder

Interventions

Type	Name	Description
DEVICE	Digital Therapeutic (Version 1)	Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD
DEVICE	Digital Therapeutic (Version 2)	Prescription digital therapeutic (increased dose) designed to overcome existing barriers and deliver evidence-based treatment for PTSD
BEHAVIORAL	Treatment as Usual (TAU)	Treatment as usual may include psychotherapy and/or pharmacological interventions.

Timeline

• Start date: 2025-06-30
• Primary completion: 2026-01-30
• Completion: 2026-01-30
• First posted: 2025-03-11
• Last updated: 2025-06-19