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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2032240310

Enrollment

Registered

2024-09-02

Start date

2024-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Traumatic Stress Disorder (PTSD)

Interventions

Software as a Medical Device

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosis of PTSD according to the DSM-5 Subjects who are within 1 to 20 years since index trauma

Exclusion criteria

Exclusion criteria: 1. Subjects diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, bipolar I disorder, autism spectrum disorder, or intellectual disability based on DSM-5. 2. 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 3. Subjects who have completed two or more full courses of trauma-focused therapy in the past

Design outcomes

Primary

Measure	Time frame
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)	—

Contacts

Public ContactKentaro Ishinabe

Otsuka Medical Devices Co., Ltd.

OtsukaRegistry-CT@otsuka.jp+81-3-6361-7459

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026