NCT05716555Unknown不适用
Safety and Efficacy of Deep Brain Stimulation for Treatment Resistant Depression
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2021年3月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale
研究概览
简要总结
This study will investigate the safety and efficacy of deep brain stimulation (DBS) in lateral habenula (LH) for patients with treatment-resistant depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70, regardless of gender;
- •Diagnostic And Statistical Manual Of Mental Disorders 5th Ed (DSM-V), for Psychiatrists' Examination of Severe Depressive Disorders;
- •Same diagnostic conclusions based on DSM-V made by two independent psychiatrists;
- •A minimum of 24 months of depressive history, over 2 or more adequate antidepressant trials with Hamilton Depression Rating Scale (HAMD) reduction rate ≤20% (including MECT) ;
- •HAMD-17 scores ⩾ 20 at screening;
- •Functional General Assessment Table (GAF) rating ≤50;
- •Able to comply with the operational and administrative requirements of participation in the study, and able to give written informed consent.
排除标准
- •Patients with severe or unstable mental, liver, kidney, endocrine, hematological diseases, or those with psychotic co-morbidities, including personality disorders;
- •History of substance abuse in the past 12 months; history of epilepsy, or febrile seizure in childhood;
- •Patients who have attempted suicide within the past 6 months, or have had a secondary suicide attempt within the past 2 years;
- •Women who are breastfeeding, pregnant, or intend to be pregnant during the clinical study;
- •Any surgical contraindications to undergoing deep brain stimulation (DBS);
- •Patients who cannot give full informed consent.
结局指标
主要结局
Hamilton Depression Rating Scale
时间窗: 52 weeks after surgery
Change in Hamilton Depression Rating Scale score from baseline to 52 weeks after surgery
次要结局
未报告次要终点
研究者
Hemmings Wu
Neurosurgeon, Assistant Professor
Second Affiliated Hospital, School of Medicine, Zhejiang University
研究点 (1)
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