Frontlight ResearchEarly access
Active, not recruitingPhase 2/3
Software as a Medical Device for the Treatment of Patients With PTSD
Key facts
- Who runs it
- Otsuka Medical Devices Co., Ltd. Japan
- Where
- Japan35 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- Phase
- Phase 2/3
- People taking part
- 52 people, planned
- Started
- 1 Sept 2024
- Expected to end
- 31 Jan 2028
- Type of study
- Interventional, 2 groups
- Treatments tested
- Software as a Medical Device
- Record updated
- 19 October 2026
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- Diagnosis of PTSD according to the DSM-5
- Subjects who are within 1 to 20 years since index trauma
Who cannot take part
- 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
- Subjects diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, bipolar I disorder, autism spectrum disorder, or intellectual disability based on DSM-5
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
To evaluate the efficacy and safety of Software as a Medical Device in patients with Post-Traumatic Stress Disorder (PTSD)
The 2 groups in the trial
- The Software as a Medical Device1Treatment being tested
Treatment: Software as a Medical Device
- The Software as a Medical Device2Other group
Treatment: Software as a Medical Device
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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)
- Record updated
- 19 October 2026