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

Phase 2

Recruiting

• Conditions: Post-Traumatic Stress Disorder, PTSD
• Interventions: Device: Software as a Medical Device

• Registration Number: NCT06589505
• Lead Sponsor: Otsuka Medical Devices Co., Ltd. Japan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-22
• Study Start: 2024-09-01
• Study First Submitted QC: 2024-09-09
• Study First Posted: 2024-09-19
• Status Verified: 2024-10
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-03
• Primary Completion: 2028-01-31
• Study Completion: 2028-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Software as a Medical Device1	Software as a Medical Device	-
The Software as a Medical Device2	Software as a Medical Device	-

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (33)

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

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