TCTR20230824007招募中1 期
An 8-week, multicenter, randomized, parallel-group trial to evaluate the efficacy and safety of VR digital therapies in patients with major depressive disorder who are inadequately responding to antidepressants
ational Center for Global Health and Medicine (NCGM)0 个研究点目标入组 100 人开始时间: 2023年8月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
- 18 Years 至 N/A (No limit)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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).
研究者
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