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

November 20, 2025 updated by: Otsuka Medical Devices Co., Ltd. Japan

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Akita, Japan
        • Recruiting
        • Heart Care Clinic Omachi
        • Contact:
          • Kentaro Ishinabe
      • Fukuoka, Japan
        • Recruiting
        • Ai Sakura Clinic
        • Contact:
          • Kentaro Ishinabe
      • Fukuoka, Japan
        • Recruiting
        • Aburayama Hospital
        • Contact:
          • Kentaro Ishinabe
      • Fukuoka, Japan
        • Recruiting
        • Hatakeyama Clinic
        • Contact:
          • Kentaro Ishinabe
      • Fukuoka, Japan
        • Recruiting
        • Hiro Mental Clinic
        • Contact:
          • Kentaro Ishinabe
      • Fukuoka, Japan
        • Recruiting
        • Hirota Clinic
        • Contact:
          • Kentaro Ishinabe
      • Fukuoka, Japan
        • Recruiting
        • Kurume University Hospital
        • Contact:
          • Kentaro Ishinabe
      • Fukuoka, Japan
        • Recruiting
        • Medical corporation Shinseikai Kaku Mental Clinic
        • Contact:
          • Kentaro Ishinabe
      • Fukuoka, Japan
        • Recruiting
        • Mental Clinic Sakurazaka
        • Contact:
          • Kentaro Ishinabe
      • Fukuoka, Japan
        • Recruiting
        • Nishie Kokorono Clinic
        • Contact:
          • Kentaro Ishinabe
      • Fukuoka, Japan
        • Recruiting
        • Uematsu Mental Clinic
        • Contact:
          • Kentaro Ishinabe
      • Gunma, Japan
        • Recruiting
        • PTSD Care Matsumoto Mental Clinic
        • Contact:
          • Kentaro Ishinabe
      • Hokkaido, Japan
        • Recruiting
        • Goryokai Hospital
        • Contact:
          • Kentaro Ishinabe
      • Hyōgo, Japan
        • Recruiting
        • Sakamoto Misako Mental Clinic
        • Contact:
          • Kentaro Ishinabe
      • Hyōgo, Japan
        • Recruiting
        • Takahashi Psychiatric Clinic
        • Contact:
          • Kentaro Ishinabe
      • Ibaraki, Japan
        • Recruiting
        • Tsukuba Psychosomatics Clinic
        • Contact:
          • Kentaro Ishinabe
      • Kanagawa, Japan
        • Recruiting
        • Musashikosugi J Kokorono Clinic
        • Contact:
          • Kentaro Ishinabe
      • Kumamoto, Japan
        • Recruiting
        • Niki Hearty Hospital
        • Contact:
          • Kentaro Ishinabe
      • Nagasaki, Japan
        • Recruiting
        • Arata Clinic
        • Contact:
          • Kentaro Ishinabe
      • Okayama, Japan
        • Recruiting
        • Okayama Psychiatric Medical Center
        • Contact:
          • Kentaro Ishinabe
      • Okinawa, Japan
        • Recruiting
        • Barclay Imuro Mental Clinic
        • Contact:
          • Kentaro Ishinabe
      • Osaka, Japan
        • Recruiting
        • Medical Corporation Mikokorokai Shimizu Clinic
        • Contact:
          • Kentaro Ishinabe
      • Saitama, Japan
        • Recruiting
        • Sho Midori Hospital
        • Contact:
          • Kentaro Ishinabe
      • Tochigi, Japan
        • Recruiting
        • Ai Mental Clinic
        • Contact:
          • Kentaro Ishinabe
      • Tokyo, Japan
        • Recruiting
        • Nippon Medical School Hospital
        • Contact:
          • Kentaro Ishinabe
      • Tokyo, Japan
        • Recruiting
        • Maynds Tower Mental Clinic
        • Contact:
          • Kentaro Ishinabe
      • Tokyo, Japan
        • Recruiting
        • Ikebukuro Olive Mental Clinic
        • Contact:
          • Kentaro Ishinabe
          • Phone Number: +81-3-6361-7459
      • Tokyo, Japan
        • Recruiting
        • i Kokoro Clinic Nihonbashi
        • Contact:
          • Kentaro Ishinabe
      • Tokyo, Japan
        • Recruiting
        • Iidabashi Mental Clinic
        • Contact:
          • Kentaro Ishinabe
      • Tokyo, Japan
        • Recruiting
        • Kitaikebukuro Kokoro No Clinic
        • Contact:
          • Kentaro Ishinabe
      • Tokyo, Japan
        • Recruiting
        • Monzennakacho Mental Clinic
        • Contact:
          • Kentaro Ishinabe
      • Tokyo, Japan
        • Recruiting
        • Sakurazaka Clinic SophyAnce
        • Contact:
          • Kentaro Ishinabe
      • Tokyo, Japan
        • Recruiting
        • Sangenjaya Nakamura Mental Clinic
        • Contact:
          • Kentaro Ishinabe
      • Tokyo, Japan
        • Recruiting
        • Wakamatsucho Kokoro to Hifu Clinic
        • Contact:
          • Kentaro Ishinabe
    • Hokkaido
      • Yamanashi, Hokkaido, Japan
        • Recruiting
        • Yamanashi Prefectural Kita Hospital
        • Contact:
          • Kentaro Ishinabe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of PTSD according to the DSM-5
  • Subjects who are within 1 to 20 years since index trauma

Exclusion Criteria:

  • Subjects diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, bipolar I disorder, autism spectrum disorder, or intellectual disability based on DSM-5.
  • Subjects diagnosed with any mood disorder and anxiety disorder according to DSM-5 that is the primary focus of treatment in the last 6 months prior to screening, as per the clinical judgement of the investigator
  • Subjects who have completed two or more full courses of trauma-focused therapy in the past

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The Software as a Medical Device1
Device: Software as a Medical Device
The subject will undergo treatment using the Software as a Medical Device
Other: The Software as a Medical Device2
Device: Software as a Medical Device
The subject will undergo treatment using the Software as a Medical Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician-Administered PTSD Scale for DSM-5
Time Frame: baseline and after intervention (up to 21 weeks)

The primary objective of this study is to assess the change from baseline of the Clinician Administered PTSD Scale (CAPS - 5) score.

Scores range from 0 - 80, with higher scores indicating increased PTSD symptom severity.
baseline and after intervention (up to 21 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Medical Devices Co., Ltd. Japan

Collaborators

Otsuka Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

August 22, 2024

First Submitted That Met QC Criteria

September 9, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 380-102-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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