Post-Traumatic Stress Disorder, PTSD
Conditions
Brief summary
To evaluate the efficacy and safety of Software as a Medical Device in patients with Post-Traumatic Stress Disorder (PTSD)
Interventions
The subject will undergo treatment using the Software as a Medical Device
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Otsuka Medical Devices Co., Ltd. Japan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician-Administered PTSD Scale for DSM-5 | baseline and after intervention (up to 21 weeks) | The primary objective of this study is to assess the change from baseline of the Clinician Administered PTSD Scale (CAPS - 5) score. Scores range from 0 - 80, with higher scores indicating increased PTSD symptom severity. |
Countries
Japan
Contacts
Primary ContactKentaro Ishinabe
Outcome results
None listed