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

Last updated: April 2, 2025
Sponsor: Otsuka Medical Devices Co., Ltd. Japan
Overall Status: Active - Recruiting

Phase

2/3

Condition

Post-traumatic Stress Disorders

Treatment

Software as a Medical Device

Clinical Study ID

NCT06589505
380-102-0001
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of PTSD according to the DSM-5

  • Subjects who are within 1 to 20 years since index trauma

Exclusion

Exclusion Criteria:

  • Subjects diagnosed with schizophrenia, schizoaffective disorder, schizophreniformdisorder, delusional disorder, bipolar I disorder, autism spectrum disorder, orintellectual disability based on DSM-5.

  • Subjects diagnosed with any mood disorder and anxiety disorder according to DSM-5that is the primary focus of treatment in the last 6 months prior to screening, asper the clinical judgement of the investigator

  • Subjects who have completed two or more full courses of trauma-focused therapy inthe past

Study Design

Total Participants: 52
Treatment Group(s): 1
Primary Treatment: Software as a Medical Device
Phase: 2/3
Study Start date:
September 01, 2024
Estimated Completion Date:
January 31, 2028

Connect with a study center

  • Heart Care Clinic Omachi

    Akita,
    Japan

    Active - Recruiting

  • Aburayama Hospital

    Fukuoka,
    Japan

    Active - Recruiting

  • Ai Sakura Clinic

    Fukuoka,
    Japan

    Active - Recruiting

  • Hatakeyama Clinic

    Fukuoka,
    Japan

    Active - Recruiting

  • Hiro Mental Clinic

    Fukuoka,
    Japan

    Active - Recruiting

  • Hirota Clinic

    Fukuoka,
    Japan

    Active - Recruiting

  • Kurume University Hospital

    Fukuoka,
    Japan

    Active - Recruiting

  • Medical corporation Shinseikai Kaku Mental Clinic

    Fukuoka,
    Japan

    Active - Recruiting

  • Mental Clinic Sakurazaka

    Fukuoka,
    Japan

    Active - Recruiting

  • Nishie Kokorono Clinic

    Fukuoka,
    Japan

    Active - Recruiting

  • Uematsu Mental Clinic

    Fukuoka,
    Japan

    Active - Recruiting

  • PTSD Care Matsumoto Mental Clinic

    Gunma,
    Japan

    Active - Recruiting

  • Goryokai Hospital

    Hokkaido,
    Japan

    Active - Recruiting

  • Sakamoto Misako Mental Clinic

    Hyōgo,
    Japan

    Active - Recruiting

  • Takahashi Psychiatric Clinic

    Hyōgo,
    Japan

    Active - Recruiting

  • Musashikosugi J Kokorono Clinic

    Kanagawa,
    Japan

    Active - Recruiting

  • Niki Hearty Hospital

    Kumamoto,
    Japan

    Active - Recruiting

  • Arata Clinic

    Nagasaki,
    Japan

    Active - Recruiting

  • Okayama Psychiatric Medical Center

    Okayama,
    Japan

    Active - Recruiting

  • Barclay Imuro Mental Clinic

    Okinawa,
    Japan

    Active - Recruiting

  • Medical Corporation Mikokorokai Shimizu Clinic

    Osaka,
    Japan

    Active - Recruiting

  • Sho Midori Hospital

    Saitama,
    Japan

    Active - Recruiting

  • Ai Mental Clinic

    Tochigi,
    Japan

    Active - Recruiting

  • Iidabashi Mental Clinic

    Tokyo,
    Japan

    Active - Recruiting

  • Ikebukuro Olive Mental Clinic

    Tokyo,
    Japan

    Active - Recruiting

  • Kitaikebukuro Kokoro No Clinic

    Tokyo,
    Japan

    Active - Recruiting

  • Maynds Tower Mental Clinic

    Tokyo,
    Japan

    Active - Recruiting

  • Monzennakacho Mental Clinic

    Tokyo,
    Japan

    Active - Recruiting

  • Nippon Medical School Hospital

    Tokyo,
    Japan

    Active - Recruiting

  • Sakurazaka Clinic SophyAnce

    Tokyo,
    Japan

    Active - Recruiting

  • Sangenjaya Nakamura Mental Clinic

    Tokyo,
    Japan

    Active - Recruiting

  • Wakamatsucho Kokoro to Hifu Clinic

    Tokyo,
    Japan

    Active - Recruiting

  • i Kokoro Clinic Nihonbashi

    Tokyo,
    Japan

    Active - Recruiting

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