An 8-week, multicenter, randomized trial to evaluate the efficacy and safety of VR digital therapies in patients with major depressive disorder who are inadequately responding to antidepressants - VRT 2201

ational Center for Global Health and Medicine0 sites100 target enrollmentNovember 27, 2023

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: ational Center for Global Health and Medicine
Enrollment: 100
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 27, 2023

End Date

March 31, 2025

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

ational Center for Global Health and Medicine

Eligibility Criteria

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).