DBS in Treatment Resistant Major Depression
DEEP BRAIN STIMULATION IN TREATMENT RESISTANT MAJOR DEPRESSION. Controlled and Crossed Study on Efficacy and Safety.
This study aims at assessing efficacy and safety of DBS for treatment of patients suffering from resistant major depression, by means of a random, controlled and crossed study.
研究概览
详细说明
The first phase of the study will consist of implanting electrodes and applying continuous stimulation until the patients stabilise clinically.
This period is anticipated between 6 and 9 months.
The next phase will consist of the crossover study.
Responders will be randomised to either of 2 groups for a period of 3 months: a stimulation-on group and a stimulation-off group.
Patients will then be crossed over to the other group for a further 3 months.
Fortnightly visits will be made during the entire study to evaluate treatment efficacy and patient tolerance
研究类型
介入性
注册 (实际的)
8
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Barcelona、西班牙、08025
- Hospital Santa Creu i Sant Pau
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients of both sexes aged between 18 and 70 years.
- Patients diagnosed as having an MDD episode according to DSM-IV-TR criteria, resistant to pharmacological treatment with a score of 4 in the Thase-Rush index, with ECT contraindicated or having failed to produce a maintained response.
- Patients with a HRSD-17 score of 18 or more.
- Patients with an intellectual capacity that facilitates adequate communication and who are willing to cooperate with all the examinations and protocols of the study.
- Patients who have not modified their antidepressant treatment in the month prior to the study.
- Women of childbearing age using medically approved contraceptive methods.
- Patients who have granted their informed consent in writing.
Exclusion Criteria:
- Female patients who are pregnant or breastfeeding.
- Patients with acute, serious or unstable illnesses.
- Patients experiencing delirium or hallucinations, congruent or otherwise with their mood.
- Patients with a history of substance abuse (other than tobacco or caffeine).
- Patients with concomitant psychiatric disorders from axes I or II of DSM IV-TR.
h)Patients with general contraindications for DBS (pacemaker users, etc).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：stimulation on
At first stage, electrodes will be implanted in all patients, who will be continuously stimulated for several months.
After this stage, the random-crossed part of the study will start, and patients who responded to DBS will be randomly distributed in two groups: on stimulation or off stimulation group, for the next three months.
Subsequently, patients will be allocated in the other group (on or off, crossed part) for three months
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Surgical electrode implantation in the white matter adjacent to the Cg25 region and implantation of the DBS pulse generating device
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安慰剂比较：Stimulation off
At first stage, electrodes will be implanted in all patients, who will be continuously stimulated for several months.
After this stage, the random-crossed part of the study will start, and patients who responded to DBS will be randomly distributed in two groups: on stimulation or off stimulation group, for the next three months.
Subsequently, patients will be allocated in the other group (on or off, crossed part) for three months
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Surgical electrode implantation in the white matter adjacent to the Cg25 region and implantation of the DBS pulse generating device
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Hamilton Rating Scale for Depression, 17-item version (HRSD-17)
大体时间：Psychiatric assessments will be performed every two weeks
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Psychiatric assessments will be performed every two weeks
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Montgomery-Asberg Depression Rating scale (MADRS) Clinical Global Impression (CGI) of Severity/Improvement Neuropsychological variables
大体时间：Psychiatric assessments will be performed every two weeks
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Psychiatric assessments will be performed every two weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Perez Sola Víctor, MD、Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- 首席研究员：Molet Joan, MD、Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Puigdemont D, Portella M, Perez-Egea R, Molet J, Gironell A, de Diego-Adelino J, Martin A, Rodriguez R, Alvarez E, Artigas F, Perez V. A randomized double-blind crossover trial of deep brain stimulation of the subcallosal cingulate gyrus in patients with treatment-resistant depression: a pilot study of relapse prevention. J Psychiatry Neurosci. 2015 Jul;40(4):224-31. doi: 10.1503/jpn.130295.
- Puigdemont D, Perez-Egea R, Portella MJ, Molet J, de Diego-Adelino J, Gironell A, Radua J, Gomez-Anson B, Rodriguez R, Serra M, de Quintana C, Artigas F, Alvarez E, Perez V. Deep brain stimulation of the subcallosal cingulate gyrus: further evidence in treatment-resistant major depression. Int J Neuropsychopharmacol. 2012 Feb;15(1):121-33. doi: 10.1017/S1461145711001088. Epub 2011 Jul 22.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年1月1日
初级完成 (预期的)
2011年6月1日
研究完成 (预期的)
2011年6月1日
研究注册日期
首次提交
2010年12月28日
首先提交符合 QC 标准的
2010年12月28日
首次发布 (估计)
2010年12月29日
研究记录更新
最后更新发布 (估计)
2010年12月29日
上次提交的符合 QC 标准的更新
2010年12月28日
最后验证
2010年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.