Recruiting NCT06589505
Software as a Medical Device for the Treatment of Patients With PTSD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Software as a Medical Device.
- Who it may be relevant to
- Registry conditions: Post-Traumatic Stress Disorder, PTSD. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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)
Overview
To evaluate the efficacy and safety of Software as a Medical Device in patients with Post-Traumatic Stress Disorder (PTSD)
Interventions
- Device Software as a Medical Device
The subject will undergo treatment using the Software as a Medical Device
Primary outcome measures
- Clinician-Administered PTSD Scale for DSM-5 [Time frame: baseline and after intervention (up to 21 weeks)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Japan · 35 centers
- Yamanashi Prefectural Kita Hospital — Yamanashi
- Heart Care Clinic Omachi — Akita
- Aburayama Hospital — Fukuoka
- Ai Sakura Clinic — Fukuoka
- Hatakeyama Clinic — Fukuoka
- Hiro Mental Clinic — Fukuoka
- Hirota Clinic — Fukuoka
- Kurume University Hospital — Fukuoka
- … and 27 more centers
Identifiers
NCT: NCT06589505 · 380-102-0001