A comparative study to evaluate the efficacy of ECT and tDCS in treatment resistant depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Patient reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 2 weeks ]
研究概览
简要总结
Depression is known to mankind since years.The World Health Organization (WHO) has listed depression as fourth most urgent health problems worldwide. Depression has been projected to be the second largest killer after heart disease by the year 2020.
Patients with major depression respond to antidepressant treatment, but 10%–30% of them do not improve or show a partial response coupled with functional impairment, poor quality of life, suicide ideation and attempts, self-injurious behavior, and a high relapse rate.
treatment-resistant depression, a complex clinical problem caused by multiple risk factors, is targeted by integrated therapeutic strategies, which include optimization of medications, a combination of antidepressants, switching of antidepressants, and augmentation with non-antidepressants, psychosocial and cultural therapies, and somatic therapies including electroconvulsive therapy, repetitive transcranial magnetic stimulation, magnetic seizure therapy, deep brain stimulation, transcranial direct current stimulation, and vagus nerve stimulation.
This study aims at comparing the efficacy of ECT and tDCS in treatment resistant depression. Although the efficacy of ECT and tDCS in treatment resistant depression has been well established however a comparative study has never been done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age range 18-60 years 2.Male and Female 3.Written informed consent.
- •4.Presence of Major Depressive Disorder as per DSM V guidelines 5.Refractory to at least two anti-depressant medications.
排除标准
- •Co-morbid psychiatric diagnoses such as psychosis, bipolar disorder, substance dependence (including nicotine dependence)
- •Mental retardation, neurological disorders and severe medical illness
- •pregnancy or breast feeding 4.Diagnosis of major depressive disorder with psychotic features during the current depressive episode.
结局指标
主要结局
Patient reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 2 weeks ]
时间窗: Patient reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 2 weeks ] | Response is defined as at least a 50% improvement in Baseline BDI score at End of Treatment Visit. The End of Treatment Visit will occur 2 weeks after the Baseline Visit
Response is defined as at least a 50% improvement in Baseline BDI score at End of Treatment Visit. The End of Treatment Visit will occur 2 weeks after the Baseline Visit
时间窗: Patient reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 2 weeks ] | Response is defined as at least a 50% improvement in Baseline BDI score at End of Treatment Visit. The End of Treatment Visit will occur 2 weeks after the Baseline Visit
次要结局
- Clinician reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 2 weeks ](Number of patients with an improvement in their Baseline HAM-D score at the End of Treatment Visit. The End of Treatment Visit will occur 2 weeks after the Baseline Visit.)