JPRN-UMIN000052903尚未招募Unknown
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 个研究点目标入组 100 人开始时间: 2023年11月27日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •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).
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