Depression (DSM-5) / Major depressive disorder (MDD)
Conditions
Interventions
Active arm: VR digital therapies + standard drug therapy 13 weeks (1 week of screening + 8 weeks of administration period + 4 weeks of follow-up).Patients wear VR goggles and view VR digital treatmen
Sponsors
Japan Institute for Health Security
Mahidol University Siriraj Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: 18 years of age or older. 2. Patients who were diagnosed as having depression (DSM-5)/major depressive disorder (MDD) triggered by, or independent of, infection with SARS-CoV-2 3. Patients who received a definite diagnosis of MDD (single episode or recurrent episodes) in a DSM-5 structured interview (SCID-5) at the start of screening and had a depressive episode duration of 8 weeks to 12 months at the start of screening. 4. Patients with a rumination symptom score on the Ruminative Response Scale (RRS) of 42 or higher at the start of screening and baseline5. Patients who have not responded to one antidepressant (SSRI, SNRI, NaSSA, or TCA/non-TCA) 5. One antianxiety medication, one sleep medication, and aripiprazole as augmentation therapy, all in sufficient doses are allowed, for at least four weeks prior to the start of screening 6. Patients with a total HAM-D score of 13 to 17 at the start of screening and baseline. 7. Patients who are able to wear VR goggles. 8. Patients who are able to understand verbal instructions necessary for research accomplishment and to enter data using a smartphone or tablet.
Exclusion criteria
Exclusion criteria: 1. Patients who have met a diagnostic criterion for schizophrenia, schizoaffective psychosis, schizophreniform disorder, bipolar disorder, delusional disorder, persistent depressive disorder (dysthymia), personality disorder, mental retardation, or depression with psychotic features in accordance with DSM-5 in the evaluation at the start of screening. 2. Patients whose primary therapeutic objective was another mental disorder (other than those mentioned in the Exclusion criteria #1) within six months prior to the start of screening or at baseline (based on a clinical judgment by the investigator at each site). 3. Patients receiving lithium, valproic acid, carbamazepine, or lamotrigine within six months prior to the start of screening or at baseline. 4. Patients who started a new therapy for MDD treatment within four weeks prior to the start of screening. 5. Patients with refractory depression (Stage III or higher according to the Thase and Rush scale) 6. Patients clinically judged as having suicidal attempts during the screening period or at baseline. 7. Patients who have received electroconvulsive therapy (ECT). 8. Patients who have received magnetic stimulation therapy (rTMS therapy). 9. Patients who received structured psychotherapy (excluding supportive psychotherapy), such as cognitive behavior therapy, from four weeks prior to the start of screening. 10. Patients who are diagnosed with epilepsy. 11. Patients who are considered difficult to accomplish research due to their condition. 12. Patients who are difficult to wear VR goggles for reasons, such as hypersensibility, or who are difficult to properly view VR. 13. Other patients who are considered ineligible by the investigator (sub-investigators).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy The change in the total HAM-D score from baseline and at week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in each item of HAMD. E.g., suicide attempt, difficulty in getting to sleep, from baseline and at week 8 The change in total HAMD from baseline and at week 12 The change in the rumination symptom score, RRS, from baseline at week 8 The change in the patient's CGI depressive symptom score from baseline at week 8 The change in the WHOQoLBREF score from baseline at week 8 Records of the names of rumination episodes and the frequency of rumination Adverse events | — |
Countries
Asia(except Japan)
Contacts
Public ContactNaoki Tomotsugu
Japan Institute for Health Security Department of International Trials, Center for Clinical Sciences
Outcome results
None listed