Randomised Controlled Trial of Electroconvulsive Therapy (ECT) With Pharmacotherapy or Pharmacotherapy Alone in Relapse Prevention of Depression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 3
- 主要终点
- MADRS >20, psychiatric hospitalization or suicide
研究概览
简要总结
The purpose of the study is to determine if continuation electroconvulsive therapy (ECT) is safe and effective in relapse prevention of depression.
详细描述
Randomized multicenter clinical trial with two parallel groups. Patients with major depression (unipolar or bipolar), who have remitted with electroconvulsive therapy (ECT) are eligible. All patients receive pharmacotherapy (venlafaxine target dose 300mg/day, and lithium target dose 0,5-0,8 mmol/L). The intervention is continuation unilateral ECT weekly for the first 6 weeks thereafter every 2 weeks for one year. Depressive relapse is the primary outcome measure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MINI-PLUS verified major depressive episode (unipolar or bipolar).
- •ECT within the last 3 weeks.
- •Either Remission defined as MADRS < 10 or
- •Response defined as MADRS < 15 combined with patient assessed CGI-I of at least much improved
排除标准
- •Schizophrenia or Schizoaffective disorder
- •Addiction or Dependence
- •Kidney disease that contraindicates lithium treatment
- •Vascular or heart disease that contraindicates venlafaxine treatment
- •Uncontrolled Epilepsia
- •Age less that 18
- •Pregnancy or Lactation
研究组 & 干预措施
ECT+pharmacotherapy
Unilateral brief pulse ECT weekly for 6 weeks thereafter every 2 weeks; Venlafaxine target dose 300mg/day; Lithium target dose 0,5-0,8 mmol/L.
干预措施: Electroconvulsive therapy (Procedure)
ECT+pharmacotherapy
Unilateral brief pulse ECT weekly for 6 weeks thereafter every 2 weeks; Venlafaxine target dose 300mg/day; Lithium target dose 0,5-0,8 mmol/L.
干预措施: venlafaxine (Drug)
ECT+pharmacotherapy
Unilateral brief pulse ECT weekly for 6 weeks thereafter every 2 weeks; Venlafaxine target dose 300mg/day; Lithium target dose 0,5-0,8 mmol/L.
干预措施: Lithium (Drug)
pharmacotherapy
Venlafaxine target dose 300mg/day; Lithium 0,5-0,8 mmol/L.
干预措施: venlafaxine (Drug)
pharmacotherapy
Venlafaxine target dose 300mg/day; Lithium 0,5-0,8 mmol/L.
干预措施: Lithium (Drug)
结局指标
主要结局
MADRS >20, psychiatric hospitalization or suicide
时间窗: 1 year, all patients assessed if MADRS-S > 20 and at 2,6 and 12 months
次要结局
- Mini Mental State Examination(2,6 and 12 months)
- ADAS-cog(2,6 and 12 months)
- Autobiographical Memory Inventory -Short Form (AMI-SF)(2,6 and 12 months patients treated in Örebro)
- Clinical Global Impression-Severity(2,6 and 12 months)
- Udvalg for Kliniske Undersogelser (UKU)(2, 6 and 12 months)
- MADRS-S Montgomery Asberg Depression Rating scale- self assessment(weekly for 6 weeks thereafter every 2 weeks for a total of one year)
研究者
prof Ingemar Engström
Professor
Örebro County Council