Study of Software as a Medical Device for Treating Post-Traumatic Stress Disorder PTSD in Adults Aged 18 to 65

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a Software as a Medical Device for treating patients with Post-Traumatic Stress Disorder PTSD. This study involves participants aged 18 to 65 who have been diagnosed with PTSD based on the DSM-5 criteria and who experienced their trauma between 1 and 20 years ago. The trial is designed as a multicenter, randomized, double-blind, parallel-group study to compare different versions of the software device. Participants will be randomly assigned to use one of the two versions of the Software as a Medical Device. The treatment involves interacting with this device over a period that may last up to 21 weeks. The primary focus is to assess changes in PTSD symptoms using a clinician-administered scale specific to PTSD, conducted both at the start of the study and after the intervention period. During the study, participants will undergo evaluations including the Clinician-Administered PTSD Scale for DSM-5 to monitor their symptoms. The researchers will carefully observe safety and how well participants tolerate the device. The study is sponsored by Otsuka Medical Devices Co., Ltd. Japan and is planned to continue until January 2028, with ongoing monitoring throughout the treatment and follow-up periods.

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