Software as a Medical Device for the Treatment of Patients With PTSD
NCT ID: NCT06589505
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
52 participants
INTERVENTIONAL
2024-09-01
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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The Software as a Medical Device1
Software as a Medical Device
The subject will undergo treatment using the Software as a Medical Device
The Software as a Medical Device2
Software as a Medical Device
The subject will undergo treatment using the Software as a Medical Device
Interventions
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Software as a Medical Device
The subject will undergo treatment using the Software as a Medical Device
Eligibility Criteria
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Inclusion Criteria
* Subjects who are within 1 to 20 years since index trauma
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Otsuka Medical Devices Co., Ltd. Japan
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Other Identifiers
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380-102-0001
Identifier Type: -
Identifier Source: org_study_id
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