A randomized controlled trial to evaluate the efficacy and safety of the VR digital therapy VRT0125 in patients with depression who have not responded adequately to standard treatment
A trial of the VR digital therapy VRT0125, in patients with depression who have not responded adequately to standard treatment
Matsumura Masayo
BiPSEE Inc.
1-10-8, Dogenzaka, Shibuya-ku, Tokyo
+81-3-6555-3012
m.matsumura@bipsee.co.jp
Clinical Trial Unit
BiPSEE Inc.
1-10-8, Dogenzaka, Shibuya-ku, Tokyo
+81-3-6555-3012
vrt0125@bipsee.co.jp
Recruiting
July. 01, 2026
July. 29, 2026
240
Interventional
randomized controlled trial
single blind
active control
parallel assignment
treatment purpose
1. Patients aged 18 years or older at the time of signing the informed consent form (ICF).
2. Patients with a documented diagnosis of Major Depressive Disorder (MDD) according to the DSM-5-TR criteria, meeting the following:
- The current depressive episode has persisted for at least 8 weeks (56 days) prior to enrollment.
3. Patients who have failed to achieve complete remission despite receiving standard-of-care (SOC) treatment.
- Note: Patients aged 24 years or younger at the time of informed consent are eligible even if they have not yet received mandatory standard medications.
4. Patients capable of maintaining a stable regimen of standard-of-care treatment alone for at least 4 weeks (28 days) prior to enrollment and throughout the observation period.
5. Patients with a Hamilton Depression Rating Scale (HAM-D) total score of 14 or higher at screening.
6. Patients who are able to wear VR goggles and have no clinically significant visual or auditory impairments that would interfere with the study procedures.
7. Patients with the cognitive and physical ability to understand verbal instructions and operate digital devices (e.g., smartphones, tablets) required for the clinical trial.
8. Patients who have provided voluntary written informed consent to participate in the clinical trial.
1. Patients with a history of any of the following conditions, based on DSM-5-TR:
- Schizophrenia, schizoaffective disorder, or schizophreniform disorder
- Bipolar and related disorders
- Epilepsy
- Delusional disorder
- Persistent depressive disorder (dysthymia)
- Personality disorders
- Obsessive-compulsive and related disorders
- Feeding and eating disorders
- Intellectual developmental disorder (intellectual disability)
- Major or mild neurocognitive disorders (including dementia or mild cognitive impairment)
- Depressive disorder due to another medical condition (associated with cerebrovascular disease, traumatic brain injury, or neurodegenerative diseases)
- Substance use disorders or addictive disorders
- Major depressive disorder with psychotic features
2. Patients with active, clinically significant suicidal ideation.
3. Patients who answered "yes" to questions 4 or 5 regarding suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS) or patients who answered "yes" to any of the 5 items regarding suicidal behavior within 6 months (180 days) prior to screening
4. Patients who have initiated a new treatment or modified the dosage/regimen of medications for their primary disease within 4 weeks (28 days) prior to enrollment.
5. Patients who have received structured psychotherapy (e.g., cognitive behavioral therapy [CBT], including group CBT) within 6 months (180 days) prior to enrollment.
6. Patients who have participated in another clinical trial involving an investigational drug or medical device within 8 weeks (56 days) prior to enrollment.
7. Patients with a history of receiving electroconvulsive therapy (ECT) within 6 months (180 days) prior to enrollment.
8. Patients with a history of receiving repetitive transcranial magnetic stimulation (rTMS) within 6 months (180 days) prior to enrollment.
9. Patients who have difficulty wearing VR goggles or are unable to tolerate or appropriately view VR content.
10. Any other patients deemed unsuitable for participation in the clinical trial by the investigator or sub-investigator for any medical or safety reasons.
18age old over
No limit
Both
Major Depressive Disorder
Standard Treatment:
Standard treatment must be maintained as a stable regimen, with no changes to the dosage or administration schedule, from at least 4 weeks (28 days) prior to enrollment until the completion of the 14-week observation period (consisting of a 12-week intervention phase and a 2-week follow-up phase) or study discontinuation.
Treatment Arms and Interventions:
Subjects will be assigned to one of the following three groups:
- Investigational Group: Subjects will receive VRT0125 in addition to their current standard treatment.
- Sham Group: Subjects will receive a sham version of VRT0125 in addition to their current standard treatment. .
- Control Group: Subjects will continue with standard treatment alone.
D003865
(Investigational group and Control group)
Change from baseline in HAM-D total score at Week 12
Key Secondary Endpoint
(Investigational Group and Sham Group)
Change from baseline in HAM-D total score at Week 12
Secondary Endpoints
(Investigational Group, Sham Group, Control Group)
1) Change from baseline in the HAM-D total score at Weeks 4, 8, and 14.
2) Change from baseline in the HAM-D subscale scores (e.g., anxiety/somatization, sleep, and core symptoms) at Weeks 4, 8, 12, and 14.
3) Proportion of subjects achieving remission (defined as a HAM-D total score of >= 7) at Weeks 4, 8, 12, and 14.
4) Proportion of subjects achieving response (defined as a >= 50 reduction from baseline in the HAM-D total score) at Weeks 4, 8, 12, and 14.
5) Change from baseline in the rumination symptom score of the RRS at 1-14 weeks
6) Change from baseline in the depressive symptom score of the PHQ-9 at 1-14 weeks
7) Change from baseline in the depressive symptom score of the CGI at 4, 8, 12, and 14 weeks
8) Change from baseline in the EQ-5D-5L score at 4, 8, 12, and 14 weeks
9) Change from baseline in the GAD-7 score at 4, 8, 12, and 14 weeks
10) Changes in C-SSRS scores over time at baseline and at 1, 4, 8, 12, and 14 weeks
Safety Endpoint
- Incidence and severity of adverse events (AEs) occurring from the time of enrollment through the completion of the 14-week observation period.
