a comparative study on the effectiveness of electroconvulsive therapy and ketamine in person suffering from treatment resistant depressive disorder
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 2-3 weeks ]
研究概览
简要总结
depression is known to mankind since years.The world health organization has listed depression as fourth most important 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 percent 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 amd augmentation with non-antidepressants,psychosocial and cultural therapies,somatic therapies including electroconvulsive therapy,repetitive transcranial magnetic stimulation,magnetic seizure therapy,deep brain stimulation,transcranial direct current stimulation.
this study aims at comparing the efficacy of ECT and ketamine infusion in treatment resistant depression.although the efficacy of ECT and ketamine infusion 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
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 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 5.allergy to ketamine.
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 2-3 weeks ]
时间窗: baseline and 2-3 weeks
Response is defined as at least a 50% improvement in Baseline QIDS-SR-16 score at End of Treatment Visit. The End of Treatment Visit will occur 3-5 weeks after the Baseline Visit.
时间窗: baseline and 2-3 weeks
次要结局
- clinician reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks ](Number of patients with an improvement in their Baseline MADRS score at the End of Treatment Visit. The End of Treatment Visit will occur 2-3 weeks after the Baseline Visit.)