A Randomized Controlled Study of Brahmi Ghrita Nasya (BGN) for the Amelioration of Cognitive Impairment Following Electroconvulsive Therapy in Patients with Depression.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Visual and autobiographical memories were tested using subsets of the B4ECT ReCoDe.
研究概览
简要总结
Depression is the most common psychiatric disorder in world population and ECT is considered as most effective treatment for severe , psychotic, or treatment resistant depression .Studies suggested that ECT is associated with acute deficits in cognitive domains .There is a paucity of literature to suggest efficacy of intervention on cognitive impairment following ECT. Study found that bacopa monnieri can improve higher order cognitive process and panchakarma therapy like nasya is useful in the treatment of dementia. Hence the study aims to evaluate efficacy of brahmi ghrita nasya in ameliorating ECT induced cognitive impairment in depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed patients with depression who are indicated for bifrontal electroconvulsive therapy (ECT) and are undergoing a minimum of three ECT sessions Patients who are cooperative for baseline cognitive assessment Age between 18 and 65 years.
排除标准
- •Uncontrolled diabetes mellitus or hypertension Age below 18 years or above 65 years Pregnant women Presence of any severe physical illness Intellectual disability disorder Patients undergoing bitemporal ECT or unilateral ECT Pre-existing cognitive disorder Neurological illnesses Substance use disorder (excluding nicotine dependence) Vitamin B12 deficiency or thyroid deficiency disorders.
结局指标
主要结局
Visual and autobiographical memories were tested using subsets of the B4ECT ReCoDe.
时间窗: Base line, after3 rd ECT, after 6th ECT, after last ECT
次要结局
- Verbal memory and working memory were assessed using the Rey Auditory Verbal Learning Test (RAVLT), Digit Span, and Spatial Span tests.(Verbal fluency was evaluated using the Controlled Oral Word Association Test (COWAT).)
研究者
Dr Vandana PV
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES BANGLORE