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

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

Recruiting
18-65 years
All
Phase 2/3

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Overview

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

Eligibility

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

Study details
    Post-Traumatic Stress Disorder
    PTSD

NCT06589505

Otsuka Medical Devices Co., Ltd. Japan

12 April 2025

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