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RecruitingPhase 2Phase 3NCT06589505

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

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)

Sponsor

Otsuka Medical Devices Co., Ltd. Japan

Enrollment

52 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Post Traumatic Stress Disorder (PTSD)

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

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

Exclusion Criteria3

  • 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

Interventions

DEVICESoftware as a Medical Device

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

Locations(35)

Yamanashi Prefectural Kita Hospital

Yamanashi, Hokkaido, Japan

Heart Care Clinic Omachi

Akita, Japan

Aburayama Hospital

Fukuoka, Japan

Ai Sakura Clinic

Fukuoka, Japan

Hatakeyama Clinic

Fukuoka, Japan

Hiro Mental Clinic

Fukuoka, Japan

Hirota Clinic

Fukuoka, Japan

Kurume University Hospital

Fukuoka, Japan

Medical corporation Shinseikai Kaku Mental Clinic

Fukuoka, Japan

Mental Clinic Sakurazaka

Fukuoka, Japan

Nishie Kokorono Clinic

Fukuoka, Japan

Uematsu Mental Clinic

Fukuoka, Japan

PTSD Care Matsumoto Mental Clinic

Gunma, Japan

Goryokai Hospital

Hokkaido, Japan

Sakamoto Misako Mental Clinic

Hyōgo, Japan

Takahashi Psychiatric Clinic

Hyōgo, Japan

Tsukuba Psychosomatics Clinic

Ibaraki, Japan

Musashikosugi J Kokorono Clinic

Kanagawa, Japan

Niki Hearty Hospital

Kumamoto, Japan

Arata Clinic

Nagasaki, Japan

Okayama Psychiatric Medical Center

Okayama, Japan

Barclay Imuro Mental Clinic

Okinawa, Japan

Medical Corporation Mikokorokai Shimizu Clinic

Osaka, Japan

Sho Midori Hospital

Saitama, Japan

Ai Mental Clinic

Tochigi, Japan

i Kokoro Clinic Nihonbashi

Tokyo, Japan

Iidabashi Mental Clinic

Tokyo, Japan

Ikebukuro Olive Mental Clinic

Tokyo, Japan

Kitaikebukuro Kokoro No Clinic

Tokyo, Japan

Maynds Tower Mental Clinic

Tokyo, Japan

Monzennakacho Mental Clinic

Tokyo, Japan

Nippon Medical School Hospital

Tokyo, Japan

Sakurazaka Clinic SophyAnce

Tokyo, Japan

Sangenjaya Nakamura Mental Clinic

Tokyo, Japan

Wakamatsucho Kokoro to Hifu Clinic

Tokyo, Japan

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NCT06589505

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