Feasibility study of VR digital therapies in MDD patients

Not Applicable

• Conditions: Depression (DSM-5) / Major depressive disorder (MDD)

• Registration Number: JPRN-UMIN000052903
• Lead Sponsor: ational Center for Global Health and Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-27
• Last Update Posted: 22 January 2024
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified