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

Otsuka Medical Devices

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Post-Traumatic Stress Disorder, PTSD

Treatments: Device: Software as a Medical Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT06589505

380-102-0001

Details and patient eligibility

About

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

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups

The Software as a Medical Device1

Experimental group

Treatment:

Device: Software as a Medical Device

The Software as a Medical Device2

Other group

Treatment:

Device: Software as a Medical Device