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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Otsuka Medical Devices Co., Ltd. Japan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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