NCT07316088

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

Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms in a Randomized Controlled Trial (RCT)

• Status: Recruiting
• Phase: Phase 2
• 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 efficacy of OTX-601 (intervention) compared to OTX-003 (comparator) in reducing PTSD symptoms from baseline to 7 weeks.

Conditions

• PTSD
• Post Traumatic Stress Disorder

Interventions

Type	Name	Description
DEVICE	OTX-601 Digital Therapeutic	Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD
DEVICE	OTX-003 Comparator app	Comparator designed to match interface of intervention while providing no active treatment.

Timeline

• Start date: 2025-12-09
• Primary completion: 2026-03-20
• Completion: 2026-07-31
• First posted: 2026-01-05
• Last updated: 2026-01-05

Locations

1 site across 1 country: United States