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

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

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Key information

Conditions

Post-Traumatic Stress Disorder, PTSD Combat Disorders Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Yamanashi Prefectural Kita Hospital, Yamanashi, Hokkaido, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Software as a Medical device

Device

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

Primary outcomes

Clinician-Administered PTSD Scale for DSM-5

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kentaro Ishinabe

CONTACT

[email protected]

+81-3-6361-7459

Sponsors and collaborators

Lead sponsor

Otsuka Medical Devices Co., Ltd. Japan

Industry

Collaborators

Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Parallel-group Comparative Study to Assess Efficacy and Safety of Software as a Medical Device in Patients With Post-Traumatic Stress Disorder (PTSD)

Important dates

Study start: 2024
Primary completion: 2028
Study completion: 2028
First posted: Sep 19, 2024
Registry last updated: Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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