Epidural Stimulation for Resistant Depression Treatment: A Randomized Double Blind Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Rating Scale Hamilton Depression
研究概览
简要总结
This study aims to analyze the effectiveness and feasibility of using an implantable system that provides epidural electrical stimulation directly to the left prefrontal dorsolateral cortex (Brodmann area 9/46) in patients with chronic and refractory Depressive Disorder Major.
详细描述
Exploratory Objectives
To analyze the hypothetical advantages of epidural cortical stimulation compare to less invasive method of transcranial magnetic stimulation:
- Surgical implantation of stimulating electrodes can lead to a more powerful, consistent and accurate form of stimulation to the cortex, one of the main concerns associated with the variability observed in studies of transcranial magnetic stimulation.
- A definitive system for the implantation could also overcome another disadvantage of transcranial magnetic stimulation therapy, the need of repetitive treatment period of several weeks, and the need for maintenance sessions.
- To achieve remission of depressive symptoms by promoting improved quality of life and reducing the risk of suicide.
- To improve patient adherence to the treatment by the establishment of a permanent system.
Sample:
Patients will be selected from outpatient clinics and psychiatric wards of specialized services in Distrito Federal, Brasília, Brazil. These patients will be included in a specific outpatient affective disorders at the University Hospital of Brasília. Those patients with major depressive disorder considered untreatable by conventional methods:
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion in this study requires that patients meet the criteria for recurrent Major Depressive Disorder according to the DSM V (recurrent Major Depressive Disorder without psychotic features), being in a current depressive episode lasting at least two years or have produced at least four episodes of major depression, along with the current episode lasting at least one year. All individuals must be adults, women can not be pregnant and must be submitted to contraceptive therapy
- •Subjects must have failed to respond to at least four different trials with antidepressant at therapeutic doses for a period of at least six weeks, associated with specific psychotherapy during this period and/or use of ECT or VNS. The medication treatment for depression used at the moment of selection should remain unchanged for at least eight weeks after implantation and will not change during the study period. Possible needs therapeutic adjustments during the study will be managed with changes in parameter magnetic stimulation
- •Patients should score at least 20 points on the Hamilton Rating Scale (Hamilton Depression Rating Scale-28 (HDRS))
排除标准
- •Preexisting neurological disease including epilepsy
- •Other psychiatric disorders except for anxiety disorders
- •Less than 24 Mini-Mental or any other cognitive disorder
- •Being with serious suicidal ideation
- •Medical conditions that preclude surgery as judgment of the research team
结局指标
主要结局
Change in Rating Scale Hamilton Depression
时间窗: baseline - 12 weeks - 26 weeks
assessment of severity of symptoms in depressed patients with primary depressive illness and monitoring changes due to treatment
次要结局
- Change in Scale of the SF-36(Baseline - 12 weeks -26 weeks)
- Change in Depression Scale Montgomery-Asberg Depression Rating Scale(Baseline - 12 weeks -26 weeks)
- Frequency of Side Effects Scale - (UKU- Ugvalg is Kliniske Undersgelser)(Baseline - 12 weeks - 26 weeks)
研究者
Monique Gomes da Silva Scalco
Principal Investigator
University of Brasilia