Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 65Years
All Genders
NCT06589505

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

Led by Otsuka Medical Devices Co., Ltd. Japan · Updated on 2025-11-21

52

Participants Needed

35

Research Sites

178 weeks

Total Duration

On this page

Sponsors

O

Otsuka Medical Devices Co., Ltd. Japan

Lead Sponsor

O

Otsuka Pharmaceutical Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of PTSD according to the DSM-5
  • Experienced index trauma within 1 to 20 years
  • Age between 18 and 65 years
Not Eligible

You will not qualify if you...

  • Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, bipolar I disorder, autism spectrum disorder, or intellectual disability
  • Primary mood or anxiety disorder treated in the last 6 months
  • Completed two or more full courses of trauma-focused therapy in the past

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 35 locations

1

Yamanashi Prefectural Kita Hospital

Yamanashi, Hokkaido, Japan

Actively Recruiting

2

Heart Care Clinic Omachi

Akita, Japan

Actively Recruiting

3

Aburayama Hospital

Fukuoka, Japan

Actively Recruiting

4

Ai Sakura Clinic

Fukuoka, Japan

Actively Recruiting

5

Hatakeyama Clinic

Fukuoka, Japan

Actively Recruiting

6

Hiro Mental Clinic

Fukuoka, Japan

Actively Recruiting

7

Hirota Clinic

Fukuoka, Japan

Actively Recruiting

8

Kurume University Hospital

Fukuoka, Japan

Actively Recruiting

9

Medical corporation Shinseikai Kaku Mental Clinic

Fukuoka, Japan

Actively Recruiting

10

Mental Clinic Sakurazaka

Fukuoka, Japan

Actively Recruiting

11

Nishie Kokorono Clinic

Fukuoka, Japan

Actively Recruiting

12

Uematsu Mental Clinic

Fukuoka, Japan

Actively Recruiting

13

PTSD Care Matsumoto Mental Clinic

Gunma, Japan

Actively Recruiting

14

Goryokai Hospital

Hokkaido, Japan

Actively Recruiting

15

Sakamoto Misako Mental Clinic

Hyōgo, Japan

Actively Recruiting

16

Takahashi Psychiatric Clinic

Hyōgo, Japan

Actively Recruiting

17

Tsukuba Psychosomatics Clinic

Ibaraki, Japan

Actively Recruiting

18

Musashikosugi J Kokorono Clinic

Kanagawa, Japan

Actively Recruiting

19

Niki Hearty Hospital

Kumamoto, Japan

Actively Recruiting

20

Arata Clinic

Nagasaki, Japan

Actively Recruiting

21

Okayama Psychiatric Medical Center

Okayama, Japan

Actively Recruiting

22

Barclay Imuro Mental Clinic

Okinawa, Japan

Actively Recruiting

23

Medical Corporation Mikokorokai Shimizu Clinic

Osaka, Japan

Actively Recruiting

24

Sho Midori Hospital

Saitama, Japan

Actively Recruiting

25

Ai Mental Clinic

Tochigi, Japan

Actively Recruiting

26

i Kokoro Clinic Nihonbashi

Tokyo, Japan

Actively Recruiting

27

Iidabashi Mental Clinic

Tokyo, Japan

Actively Recruiting

28

Ikebukuro Olive Mental Clinic

Tokyo, Japan

Actively Recruiting

29

Kitaikebukuro Kokoro No Clinic

Tokyo, Japan

Actively Recruiting

30

Maynds Tower Mental Clinic

Tokyo, Japan

Actively Recruiting

31

Monzennakacho Mental Clinic

Tokyo, Japan

Actively Recruiting

32

Nippon Medical School Hospital

Tokyo, Japan

Actively Recruiting

33

Sakurazaka Clinic SophyAnce

Tokyo, Japan

Actively Recruiting

34

Sangenjaya Nakamura Mental Clinic

Tokyo, Japan

Actively Recruiting

35

Wakamatsucho Kokoro to Hifu Clinic

Tokyo, Japan

Actively Recruiting

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Research Team

K

Kentaro Ishinabe

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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