NCT06589505

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
22mo left

Started Sep 2024

Typical duration for phase_2

Geographic Reach
1 country

35 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Sep 2024Jan 2028

First Submitted

Initial submission to the registry

August 22, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

November 21, 2025

Status Verified

October 1, 2025

Enrollment Period

3.4 years

First QC Date

August 22, 2024

Last Update Submit

November 20, 2025

Conditions

Post-Traumatic Stress Disorder, PTSD

Outcome Measures

Primary Outcomes (1)

  • Clinician-Administered PTSD Scale for DSM-5

    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)

Study Arms (2)

The Software as a Medical Device1

EXPERIMENTAL
Device: Software as a Medical Device

The Software as a Medical Device2

OTHER
Device: Software as a Medical Device

Interventions

Software as a Medical DeviceDEVICE

The subject will undergo treatment using the Software as a Medical Device

The Software as a Medical Device1The Software as a Medical Device2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Yamanashi Prefectural Kita Hospital

Yamanashi, Hokkaido, Japan

RECRUITING

Heart Care Clinic Omachi

Akita, Japan

RECRUITING

Aburayama Hospital

Fukuoka, Japan

RECRUITING

Ai Sakura Clinic

Fukuoka, Japan

RECRUITING

Hatakeyama Clinic

Fukuoka, Japan

RECRUITING

Hiro Mental Clinic

Fukuoka, Japan

RECRUITING

Hirota Clinic

Fukuoka, Japan

RECRUITING

Kurume University Hospital

Fukuoka, Japan

RECRUITING

Medical corporation Shinseikai Kaku Mental Clinic

Fukuoka, Japan

RECRUITING

Mental Clinic Sakurazaka

Fukuoka, Japan

RECRUITING

Nishie Kokorono Clinic

Fukuoka, Japan

RECRUITING

Uematsu Mental Clinic

Fukuoka, Japan

RECRUITING

PTSD Care Matsumoto Mental Clinic

Gunma, Japan

RECRUITING

Goryokai Hospital

Hokkaido, Japan

RECRUITING

Sakamoto Misako Mental Clinic

Hyōgo, Japan

RECRUITING

Takahashi Psychiatric Clinic

Hyōgo, Japan

RECRUITING

Tsukuba Psychosomatics Clinic

Ibaraki, Japan

RECRUITING

Musashikosugi J Kokorono Clinic

Kanagawa, Japan

RECRUITING

Niki Hearty Hospital

Kumamoto, Japan

RECRUITING

Arata Clinic

Nagasaki, Japan

RECRUITING

Okayama Psychiatric Medical Center

Okayama, Japan

RECRUITING

Barclay Imuro Mental Clinic

Okinawa, Japan

RECRUITING

Medical Corporation Mikokorokai Shimizu Clinic

Osaka, Japan

RECRUITING

Sho Midori Hospital

Saitama, Japan

RECRUITING

Ai Mental Clinic

Tochigi, Japan

RECRUITING

i Kokoro Clinic Nihonbashi

Tokyo, Japan

RECRUITING

Iidabashi Mental Clinic

Tokyo, Japan

RECRUITING

Ikebukuro Olive Mental Clinic

Tokyo, Japan

RECRUITING

Kitaikebukuro Kokoro No Clinic

Tokyo, Japan

RECRUITING

Maynds Tower Mental Clinic

Tokyo, Japan

RECRUITING

Monzennakacho Mental Clinic

Tokyo, Japan

RECRUITING

Nippon Medical School Hospital

Tokyo, Japan

RECRUITING

Sakurazaka Clinic SophyAnce

Tokyo, Japan

RECRUITING

Sangenjaya Nakamura Mental Clinic

Tokyo, Japan

RECRUITING

Wakamatsucho Kokoro to Hifu Clinic

Tokyo, Japan

RECRUITING

MeSH Terms

Conditions

Combat Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Central Study Contacts

Kentaro Ishinabe

CONTACT

+81-3-6361-7459OtsukaRegistry-CT@otsuka.jp

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2024

First Posted

September 19, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Last Updated

November 21, 2025

Record last verified: 2025-10

Locations

JP(35)