DEEP BRAIN STIMULATION IN TREATMENT RESISTANT MAJOR DEPRESSION. Controlled and Crossed Study on Efficacy and Safety.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Hamilton Rating Scale for Depression, 17-item version (HRSD-17)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (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
- •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.
排除标准
- •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).
结局指标
主要结局
Hamilton Rating Scale for Depression, 17-item version (HRSD-17)
时间窗: Psychiatric assessments will be performed every two weeks
次要结局
- Montgomery-Asberg Depression Rating scale (MADRS) Clinical Global Impression (CGI) of Severity/Improvement Neuropsychological variables(Psychiatric assessments will be performed every two weeks)