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Clinical trial No longer in our active list Phase2; Phase3 Interventional Ages 18 to 65

Using software to help treat PTSD

Official title: 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)

Run by Otsuka Medical Devices Co., Ltd. Japan · NCT06589505 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study is testing a new software app to see if it can help people with PTSD feel better after experiencing trauma in the last 1 to 20 years.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment52 (estimated)
SponsorOtsuka Medical Devices Co., Ltd. Japan
Industry-sponsored
Locations35 sites (Yamanashi, Hokkaido and 34 other locations)
Trial IDNCT06589505 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals diagnosed with PTSD who have experienced trauma within the last 1 to 20 years.

Probably not a fit

Patients with other significant mental health disorders or those who have undergone extensive trauma-focused therapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness and safety of a software application designed as a medical device for patients suffering from Post-Traumatic Stress Disorder (PTSD). It targets individuals who have experienced trauma within the last 1 to 20 years and aims to provide a novel therapeutic approach. The study will involve participants diagnosed with PTSD according to DSM-5 criteria, while excluding those with certain other mental health disorders. The intervention will be assessed through a structured methodology to determine its impact on PTSD symptoms.

Why it matters

Potential benefit: If successful, this software could provide a new, effective treatment option for patients with PTSD.

How similar studies have gone: While the use of software as a medical device for mental health treatment is an emerging field, similar approaches have shown promise in other studies, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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

Where it's running

  • 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
Show 29 more locations
  • 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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Non-invasive vagus nerve stimulation (gammaCore) for PTSD

    This study will test whether the handheld gammaCore device, which delivers mild electrical stimulation to the vagus nerve through the neck, can help adults with PTSD reduce their symptoms.

    Recruiting Acacia Clinics · Sunnyvale, California · NCT07523685

  • Building Ukraine's strength in PTSD treatment

    This project will try the Reconsolidation of Traumatic Memories (RTM) protocol alongside standard PTSD treatments to see if it reduces symptoms in adults with PTSD living in Ukraine.

    Recruiting at 2 sites University of Luxembourg · Kyiv and 1 other locations · NCT07318181

  • Emotional dysregulation in adolescents with complex trauma traits

    Researchers will observe teens to see how emotional dysregulation shows up in CPTSD and how it differs from BPD and PTSD.

    Recruiting University Hospital, Strasbourg, France · Strasbourg, Grand Est · NCT07794332

  • Grappling with Trauma: BJJ for First Responders

    This program tests whether eight weeks of Brazilian Jiu-Jitsu can be tied to changes in trauma-related symptoms for first responders who prefer movement-based activities over traditional mental health services.

    Recruiting Sam Houston State University · Conroe, Texas · NCT07783516

  • Eye Movement Intervention with Different Memory Reactivation Procedures for Intrusive Traumatic Memories

    This online trial tests whether combining eye movements with different memory reactivation tasks can reduce intrusive trauma memories in people with PTSD.

    Recruiting Shaanxi Normal University · Xi'an, Shaanxi · NCT07767396

  • Trauma-informed Psilocybin-assisted psychotherapy for PTSD

    This study tests whether adding psilocybin to trauma-focused psychotherapy helps people with PTSD see if the approach is safe and tolerable and whether symptoms improve.

    Recruiting Early Phase 1 Tel-Aviv Sourasky Medical Center · Tel Aviv · NCT07737054

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.