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Study identifier: NCT06589505 Synced from ClinicalTrials.gov · August 10, 2026
● Study status: Recruiting

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

Condition: Post-Traumatic Stress Disorder, PTSD  ·  Sponsor: Otsuka Medical Devices Co., Ltd. Japan

PhasePhase 2/Phase 3
Planned participants52
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where35 locations

Interested? Contact the study team ↓

For sponsors, CROs & site teams
Professional view of this study — listed sites, countries and recruiting context from the public registry. Everything below is written for patients and caregivers.See where this study is running →

About this study

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

This description comes directly from the study's public registry record.

Talk to the study team

Kentaro Ishinabe  ·  +81-3-6361-7459  ·  OtsukaRegistry-CT@otsuka.jp

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (35)

Yamanashi Prefectural Kita HospitalYamanashi, Hokkaido, JapanRecruiting
Heart Care Clinic OmachiAkita, JapanRecruiting
Aburayama HospitalFukuoka, JapanRecruiting
Ai Sakura ClinicFukuoka, JapanRecruiting
Hatakeyama ClinicFukuoka, JapanRecruiting
Hiro Mental ClinicFukuoka, JapanRecruiting
Hirota ClinicFukuoka, JapanRecruiting
Kurume University HospitalFukuoka, JapanRecruiting
Medical corporation Shinseikai Kaku Mental ClinicFukuoka, JapanRecruiting
Mental Clinic SakurazakaFukuoka, JapanRecruiting
Nishie Kokorono ClinicFukuoka, JapanRecruiting
Uematsu Mental ClinicFukuoka, JapanRecruiting

+ 23 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

YamanashiAkitaFukuokaGunma

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