NCT06589505

Software as a Medical Device for the Treatment of Patients With PTSD

A Multicenter, Randomized, Double-blind, Parallel-group Comparative Study to Assess Efficacy and Safety of Software as a Medical Device in Patients With Post-Traumatic Stress Disorder (PTSD)

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Otsuka Medical Devices Co., Ltd. Japan · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of Software as a Medical Device in patients with Post-Traumatic Stress Disorder (PTSD)

Conditions

• Post-Traumatic Stress Disorder, PTSD

Interventions

Type	Name	Description
DEVICE	Software as a Medical Device	The subject will undergo treatment using the Software as a Medical Device

Timeline

• Start date: 2024-09-01
• Primary completion: 2028-01-31
• Completion: 2028-01-31
• First posted: 2024-09-19
• Last updated: 2025-11-21

Locations

35 sites across 1 country: Japan