NCT07207239Enrolling By Invitation不适用
Effect of Theta-burst rTMS Therapy on the Clinical and Cognitive Symptoms of Patients With Therapy Resistant Depression and Response Prediction With Neuroimaging Methods.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Clinical symptoms
研究概览
简要总结
The primary aim of the study is to find the combination of neuroimaging-related markers, demographics, and clinical characteristics that predict the response of patients with therapy-resistant depression to theta-burst rTMS treatment. The secondary aim is to monitor the cognitive effects of TMS therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of depression
- •18 years of age
- •Beck depression inventory score above 12 (screening)
- •MADRS score above 6 (baseline)
排除标准
- •serious cognitive impairment
- •mental retardation
- •history of head injury with loss of consciousness for more than 1 hour
- •alcohol or drug abuse within the past 3 months
结局指标
主要结局
Clinical symptoms
时间窗: 120 days
The primary outcome measures are the clinical symptoms of depression measured by a clinician with the Montgomery-Åsberg Depression Rating Scale.
次要结局
- Neuroimaging characteristics(120 days)
- Patient profile(120 days)
- Cognitive functioning/Spatial working Memory(120 days)
- Cognitive functioning/Executive function(120 days)
- Cognitive functioning/reaction time(120 days)
- Clinical symptoms based on self-report questionnaires(120 days)
研究者
Gábor Csukly
Associate Professor
Semmelweis University
研究点 (2)
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