Vascular Depression and Magnetic Stimulation Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Response rates to treatment; relapse rates; the size, number, and location of the vascular lesions; and the amount of regional brain atrophy
研究概览
简要总结
This 12-week study will evaluate the effectiveness of repetitive transcranial magnetic stimulation (rTMS) of the brain, followed by citalopram (Celexa®), for treatment of depression associated with small vascular lesions in the brain (vascular depression).
详细描述
Vascular depression is a condition that typically affects the elderly and is associated with small vascular lesions. It is more resistant to treatment and has a poorer outcome than nonvascular depression. By altering excitability in the cortical area of the brain, rTMS may be an effective treatment neuropsychiatric conditions, particularly depression.
Participants in this study will be randomly assigned to 15 treatments of either rTMS or sham rTMS for 3 weeks. Following treatment, participants will receive citalopram for 9 weeks. Response rates to treatment; relapse rates; the size, number, and location of the vascular lesions; and the amount of regional brain atrophy will be measured. Improvements in activities of daily living, quality of life, and cognitive function will also be also measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 51 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV diagnosis of unipolar major or minor depressive disorder
- •Hamilton Depression Rating Scale score of at least 18
- •Depression that is associated with cerebrovascular disease
- •Failed at least 1 treatment for vascular depression
排除标准
- 未提供
研究组 & 干预措施
1
Participants will receive treatment with repetitive transcranial magnetic stimulation and citalopram.
干预措施: Repetitive transcranial magnetic stimulation (rTMS) (Procedure)
1
Participants will receive treatment with repetitive transcranial magnetic stimulation and citalopram.
干预措施: Citalopram (Drug)
2
Participants will receive treatment with sham repetitive transcranial magnetic stimulation and citalopram.
干预措施: Citalopram (Drug)
2
Participants will receive treatment with sham repetitive transcranial magnetic stimulation and citalopram.
干预措施: Sham rTMS (Procedure)
结局指标
主要结局
Response rates to treatment; relapse rates; the size, number, and location of the vascular lesions; and the amount of regional brain atrophy
时间窗: Measured at Week 12
次要结局
- Improvements in activities of daily living, quality of life, and cognitive function(Measured at Week 12)