A Controlled Study of Ultrabrief Pulsewidth ECT (Electroconvulsive Therapy)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Change in scores on Memory Tests
研究概览
简要总结
Electroconvulsive Therapy (ECT) remains essential to contemporary psychiatric practice and is one of the safest and most effective treatments available for depression. Despite modern advances in pharmacotherapy, about 15-20 per cent of all hospitalised patients receive treatment with ECT. Its use, however, is limited by concerns over associated cognitive side effects.
Recent research has suggested that using an ultrabrief pulsewidth with ECT may greatly reduce cognitive side effects, while maintaining efficacy (Sackeim et al 2008). Preliminary results were positive for unilateral ECT, however, suggest that for bilateral ECT, dosing may need to be adjusted to preserve efficacy while reducing side effects. This study will examine the relative cognitive side effects and efficacy of right unilateral and bilateral ECT given with a standard pulsewidth or an ultrabrief pulsewidth. Some participants will also receive an MRI scan before and after ECT.
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
- Double (Participant, Outcomes Assessor)
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
- •Subjects meet criteria for a DSM-IV-TR Major Depressive Episode
- •Total MADRS score >/= 25
- •Age >/= 18 years
- •Educated or working in an English medium setting
排除标准
- •Diagnosis (as defined by DSM-IV-TR) of any psychotic disorder (lifetime with exception of Major Depressive Episode with psychotic features); rapid cycling bipolar disorder, eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year).
- •history of drug or alcohol abuse or dependence (as per DSM-IV-TR) in the last 6 months (except nicotine and caffeine).
- •ECT in last 3 months
- •Subject requires an urgent clinical response due to inanition, psychosis or high suicide risk
- •unable to give informed consent
- •score < 24 on Mini Mental State Examination
研究组 & 干预措施
bilateral-ultrabrief ECT
Patients will be treated with an ultrabrief (0.3ms) pulse with a bilateral placement at 3-4 times seizure threshold.
干预措施: bilateral ultrabrief ECT (Procedure)
bilateral standard ECT
Patients will be treated with a standard (1.0ms) pulse with a bilateral placement at 1.5 times seizure threshold.
干预措施: bilateral standard ECT (Procedure)
right-unilateral ultrabrief ECT
Patients will be treated with an ultrabrief (0.3ms) pulse with a right unilateral placement at 8 times seizure threshold.
干预措施: right-unilateral ultrabrief ECT (Procedure)
right-unilateral standard ECT
Patients will be treated with a standard (1.0ms) pulse with a right unilateral placement at 5 times seizure threshold.
干预措施: right-unilateral standard ECT (Procedure)
结局指标
主要结局
Change in scores on Memory Tests
时间窗: Before ECT, after 6 ECT treatments, after final ECT treatment, one month and six month follow-up
次要结局
- Change in scores on Depression Rating Scale(Before ECT, after each week of treatment, at the end of the ECT course)