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

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)

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

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