jRCT2052260059招募中不适用
A randomized controlled trial to evaluate the efficacy and safety of the VR digital therapy VRT0125 in patients with depression who have not responded adequately to standard treatment
未提供0 个研究点目标入组 240 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients aged 18 years or older at the time of signing the informed consent form (ICF).
- •Patients with a documented diagnosis of Major Depressive Disorder (MDD) according to the DSM-5-TR criteria, meeting the following:
- •The current depressive episode has persisted for at least 8 weeks (56 days) prior to enrollment.
- •Patients who have failed to achieve complete remission despite receiving standard-of-care (SOC) treatment.
- •Note: Patients aged 24 years or younger at the time of informed consent are eligible even if they have not yet received mandatory standard medications.
- •Patients capable of maintaining a stable regimen of standard-of-care treatment alone for at least 4 weeks (28 days) prior to enrollment and throughout the observation period.
- •Patients with a Hamilton Depression Rating Scale (HAM-D) total score of 14 or higher at screening.
- •Patients who are able to wear VR goggles and have no clinically significant visual or auditory impairments that would interfere with the study procedures.
- •Patients with the cognitive and physical ability to understand verbal instructions and operate digital devices (e.g., smartphones, tablets) required for the clinical trial.
- •Patients who have provided voluntary written informed consent to participate in the clinical trial.
排除标准
- •Patients with a history of any of the following conditions, based on DSM-5-TR:
- •Schizophrenia, schizoaffective disorder, or schizophreniform disorder
- •Bipolar and related disorders
- •Delusional disorder
- •Persistent depressive disorder (dysthymia)
- •Personality disorders
- •Obsessive-compulsive and related disorders
- •Feeding and eating disorders
- •Intellectual developmental disorder (intellectual disability)
- •Major or mild neurocognitive disorders (including dementia or mild cognitive impairment)
- •Depressive disorder due to another medical condition (associated with cerebrovascular disease, traumatic brain injury, or neurodegenerative diseases)
- •Substance use disorders or addictive disorders
- •Major depressive disorder with psychotic features
- •Patients with active, clinically significant suicidal ideation.
- •Patients who answered "yes" to questions 4 or 5 regarding suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS) or patients who answered "yes" to any of the 5 items regarding suicidal behavior within 6 months (180 days) prior to screening
- •Patients who have initiated a new treatment or modified the dosage/regimen of medications for their primary disease within 4 weeks (28 days) prior to enrollment.
- •Patients who have received structured psychotherapy (e.g., cognitive behavioral therapy [CBT], including group CBT) within 6 months (180 days) prior to enrollment.
- •Patients who have participated in another clinical trial involving an investigational drug or medical device within 8 weeks (56 days) prior to enrollment.
- •Patients with a history of receiving electroconvulsive therapy (ECT) within 6 months (180 days) prior to enrollment.
- •Patients with a history of receiving repetitive transcranial magnetic stimulation (rTMS) within 6 months (180 days) prior to enrollment.
- •Patients who have difficulty wearing VR goggles or are unable to tolerate or appropriately view VR content.
- •Any other patients deemed unsuitable for participation in the clinical trial by the investigator or sub-investigator for any medical or safety reasons.
研究者
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