Post-Traumatic Stress Disorder, PTSDPhase 2/3NCT06589505
Software as a Medical Device for the Treatment of Patients With PTSD
A Phase 2/3 study testing Software as a Medical Device in people with Post-Traumatic Stress Disorder, PTSD, run by Otsuka Medical Devices Co., Ltd. Japan at 35 sites in Japan.
Trial summary
To evaluate the efficacy and safety of Software as a Medical Device in patients with Post-Traumatic Stress Disorder (PTSD) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Traumatic Stress Disorder, PTSD
- What is being tested?
- Software as a Medical Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 35 sitesJapan
- Study dates
- 1 Sep 2024to 31 Jan 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PTSD according to the DSM-5
- Subjects who are within 1 to 20 years since index trauma
Who cannot join
- 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 locations and contacts
35 sites in 1 country.
35 sites in 1 country
Japan35 sites
Heart Care Clinic Omachi
Akita
Aburayama Hospital
Fukuoka
Ai Sakura Clinic
Fukuoka
Hatakeyama Clinic
Fukuoka
Hiro Mental Clinic
Fukuoka
Hirota Clinic
Fukuoka
Kurume University Hospital
Fukuoka
Medical corporation Shinseikai Kaku Mental Clinic
Fukuoka
Mental Clinic Sakurazaka
Fukuoka
Nishie Kokorono Clinic
Fukuoka
Uematsu Mental Clinic
Fukuoka
PTSD Care Matsumoto Mental Clinic
Gunma
Goryokai Hospital
Hokkaido
Sakamoto Misako Mental Clinic
Hyōgo
Takahashi Psychiatric Clinic
Hyōgo
Tsukuba Psychosomatics Clinic
Ibaraki
Musashikosugi J Kokorono Clinic
Kanagawa
Niki Hearty Hospital
Kumamoto
Arata Clinic
Nagasaki
Okayama Psychiatric Medical Center
Okayama
Barclay Imuro Mental Clinic
Okinawa
Medical Corporation Mikokorokai Shimizu Clinic
Osaka
Sho Midori Hospital
Saitama
Ai Mental Clinic
Tochigi
i Kokoro Clinic Nihonbashi
Tokyo
Iidabashi Mental Clinic
Tokyo
Ikebukuro Olive Mental Clinic
Tokyo
Kitaikebukuro Kokoro No Clinic
Tokyo
Maynds Tower Mental Clinic
Tokyo
Monzennakacho Mental Clinic
Tokyo
Nippon Medical School Hospital
Tokyo
Sakurazaka Clinic SophyAnce
Tokyo
Sangenjaya Nakamura Mental Clinic
Tokyo
Wakamatsucho Kokoro to Hifu Clinic
Tokyo
Yamanashi Prefectural Kita Hospital
Yamanashi, Hokkaido
About this study
Official title: 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)
- Conditions
- Post-Traumatic Stress Disorder, PTSD
- Being tested
- Software as a Medical Device
- Medical subject headings
- Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Software as a Medical DeviceDevice
The subject will undergo treatment using the Software as a Medical Device
| Study group | Role | What they receive |
|---|---|---|
| The Software as a Medical Device1 | Experimental | Not described Receives: Device: Software as a Medical Device |
| The Software as a Medical Device2 | Other | Not described Receives: Device: Software as a Medical Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered PTSD Scale for DSM-5
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.
Measured: baseline and after intervention (up to 21 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Sep 2024
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress Disorder, PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otsuka Medical Devices Co., Ltd. Japan
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589505
- Sponsor's protocol ID
- 380-102-0001
- Status last verified
- Oct 2026
- First submitted
- 22 Aug 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06589505
- Acronym / sponsor ID
- 380-102-0001
- Conditions
- Post-Traumatic Stress Disorder, PTSD
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Otsuka Medical Devices Co., Ltd. JapanIndustry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of Software as a Medical Device in patients with Post-Traumatic Stress Disorder (PTSD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Software as a Medical Device1 | Experimental | Device: Software as a Medical Device |
| The Software as a Medical Device2 | Other | Device: Software as a Medical Device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of PTSD according to the DSM-5
- Subjects who are within 1 to 20 years since index trauma
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Software as a Medical DeviceThe subject will undergo treatment using the Software as a Medical Device | Device | The Software as a Medical Device1, The Software as a Medical Device2 |
Primary outcome
Clinician-Administered PTSD Scale for DSM-5
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Software as a Medical Device in people with Post-Traumatic Stress Disorder, PTSD, run by Otsuka Medical Devices Co., Ltd. Japan at 35 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Administered PTSD Scale for DSM-5 (time frame: baseline and after intervention (up to 21 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.