Status:
RECRUITING
Software as a Medical Device for the Treatment of Patients With PTSD
Lead Sponsor:
Otsuka Medical Devices Co., Ltd. Japan
Collaborating Sponsors:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Post-Traumatic Stress Disorder, PTSD
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
To evaluate the efficacy and safety of Software as a Medical Device in patients with Post-Traumatic Stress Disorder (PTSD)
Eligibility Criteria
Inclusion
- Diagnosis of PTSD according to the DSM-5
- Subjects who are within 1 to 20 years since index trauma
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2028
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06589505
Start Date
September 1 2024
End Date
January 31 2028
Last Update
November 21 2025
Active Locations (35)
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1
Yamanashi Prefectural Kita Hospital
Yamanashi, Hokkaido, Japan
2
Heart Care Clinic Omachi
Akita, Japan
3
Aburayama Hospital
Fukuoka, Japan
4
Ai Sakura Clinic
Fukuoka, Japan