Comparative Efficacy of Electroconvulsive Therapy Versus Intravenous Ketamine in Treatment-Resistant Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Montgomery-Åsberg Depression Rating Scale
研究概览
简要总结
This study aimed to compare the efficacy, safety, and tolerability of electroconvulsive therapy (ECT) versus intravenous (IV) ketamine in adults with treatment-resistant major depressive disorder (TRD).
详细描述
Treatment resistant depression is defined as a lack of adequate response to at least two antidepressant trials of sufficient dose, duration, and adherence in the current depressive episode.
Recent studies estimate treatment-resistant depression (TRD) by 30% of people with major depressive disorder (MDD) leading to significant challenges in care. This condition can increase disability, healthcare costs, and suicide risk, making effective treatments crucial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-75 years.
- •Current diagnosis of major depressive disorder (MDD) according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
- •Treatment resistance defined as failure to respond to ≥2 adequate antidepressant trials in the current episode.
- •Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥
- •Capacity to provide informed consent.
排除标准
- •History of psychotic disorders or bipolar disorder.
- •Current substance use disorder.
- •Significant neurological disorders or traumatic brain injury.
- •Uncontrolled hyper- tension.
- •cardiovascular diseases in the past six months.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
ECT Group
Patients received Bitemporal electroconvulsive Therapy (ECT) (2x/week for 4 weeks).
干预措施: Electroconvulsive Therapy (Drug)
Ketamine Group
Patients received intravenous (IV) ketamine 0.5 mg/kg IV infusion over 40 mins (2x/week for 4 weeks).
干预措施: Ketamine (Drug)
结局指标
主要结局
Change in Montgomery-Åsberg Depression Rating Scale
时间窗: 3 weeks post-procedure
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) was recorded from baseline to end of 3-week treatment period. The MADRS comprises the following 10 items: (1) apparent sadness; (2) reported sadness; (3) inner tension; (4) reduced sleep; (5) reduced appetite; (6) concentration difficulties; (7) lassitude; (8) inability to feel; (9) pessimistic thoughts; and (10) suicidal thoughts. With a, maximum score of 60, where higher scores indicate greater severity
次要结局
- Montreal Cognitive Assessment (MoCA)(3 weeks post-procedure)
- Patient Health Questionnaire-9 (PHQ-9)(3 weeks post-procedure)
研究者
Aya Mohamed ElNeanay
Lecture of Neurology and Psychiatry, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University