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Clinical Trials in Japan / NCT06589505
Recruiting Phase 2/3

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

NCT06589505 · tracked via the Priya Life Science Japan tracker
Sponsor
Otsuka Medical Devices Co., Ltd. Japan
Phase
Phase 2/3
Started
2024-09-01
Last updated
2025-11-21

Condition(s) studied

Post-Traumatic Stress Disorder, PTSD

Investigational drug(s) / intervention(s)

Software as a Medical Device

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Clinician-Administered PTSD Scale for DSM-5 — baseline and after intervention (up to 21 weeks)
    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.

Trial sites (35)

FacilityCityRegionStatus
Yamanashi Prefectural Kita Hospital Yamanashi Hokkaido 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

More Otsuka Medical Devices Co., Ltd. Japan trials in Japan

A Clinical Study of the Paradise™ Renal Denervation System in Patients With Hypertension (RADIANCE-HTN DUO) Active, not recruiting
A Phase I/II Study of OJP-001 in Patients With Adult T-cell Leukemia/Lymphoma Recruiting
Evaluate the Efficacy and Safety of the Cilostazol-coated BioMimics 3D Stent System in Patients with Peripheral Arterial Occlusive Disease Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06589505 on ClinicalTrials.gov ↗ ← All trials in Japan