Major Depressive Disorder (MDD) Major Depressive Disorder Depressive Disorder VR treatment
Conditions
Interventions
VR digital therapy is added to the standard drug therapy of MDD patients.,Only standard drug therapy, no VR digital therapy
Experimental Device,No Intervention Other
Active arm,Control arm
Sponsors
National Center for Global Health and Medicine (NCGM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: To be included in this study, patients should (1) have 18 years of age or older; (2) be diagnosed as having depression (DSM-5) / major depressive disorder (MDD) triggered by, or independent of, infection with SARS-CoV-2; (3) receive 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) have a rumination symptom score on the Ruminative Response Scale (RRS) of 42 or higher at the start of screening and baseline; (5) have not responded to one antidepressant (SSRI, SNRI, NaSSA, or TCA/non-TCA); (6) have a total HAM-D score of 13 to 17 at the start of screening and baseline; (7) be able to wear VR goggles; (8) be able to understand verbal instructions necessary for research accomplishment and to enter data using a smartphone or tablet.
Exclusion criteria
Exclusion criteria: Studies were excluded if patients (1) 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) 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 judgement by the investigator at each site); (3) receiving lithium, valproic acid, carbamazepine, or lamotrigine within six months prior to the start of screening or at baseline; (4) started a new therapy for MDD treatment within four weeks prior to the start of screening; (5) have refractory depression (Stage III or higher according to the Thase and Rush scale); (6) clinically judged as having suicidal attempt during the screening period or at baseline; (7) have received electroconvulsive therapy (ECT); (8) Patients who have received magnetic stimulation therapy (rTMS herapy); (9) received a structured psychotherapy (excluding supportive therapy), such as cognitive behavior therapy, from four weeks prior to the start of screening; (10) Patients who are diagnosed with epilepsy; (11) are considered difficult to accomplish research due to their condition; (12) are difficult to wear VR goggles for reasons, such as hypersensibility, or who are difficult to properly view VR; (13) are considered ineligible by the investigator (sub-investigators).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression at week 8 of treatment Change of Total HAM-D score | — |
Secondary
| Measure | Time frame |
|---|---|
| Depression From baseline and at week 8 of treatment each item of HAM-D score,Depression From baseline and at week 12 of treatment Change of Total HAM-D score,Rumination From baseline and at week 8 of treatment Change of Rumination symtom score (RRS),Depression symptom From baseline and at week 8 of treatment Change of Clinical Global Impression (CGI),Quality of Life From baseline and at week 8 of treatment Change of WHOQoL-BREF score,Rumination During treatment weeks Name and frequency of rumination,Adverse events During treatment weeks Record of Adverse events | — |
Countries
Thailand
Contacts
Public ContactNaoki Tomotsugu
Department of International Trial (DIT), National Center for Global Health and Medicine (NCGM)
Outcome results
None listed