Maintenance Electroconvulsive Therapy (ECT) Versus Aripiprazole on Psychopathology and Cerebral Perfusion in Clozapine-resistant Schizophrenia: a Randomized, Double-blind Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Change in Positive And Negative Syndome Scale score
研究概览
简要总结
The pharmacological treatment options in schizophrenia developing resistance to clozapine are limited. Few studies have found ECT as beneficial in TRS, including CRS. However, literature on the role of M-ECT in maintaining the therapeutic gains of acute ECT in CRS is lacking. The objective of the study is to compare the efficacy of M-ECT vs aripiprazole as an add-on to ongoing clozapine on the severity of symptom dimensions, cerebral perfusion, global functioning and cognitions in patients with CRS.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients clinically diagnosed with CRS (currently under clozapine)
- •Patients aged 18-60 years of either sex.
- •LAR giving voluntary written consent for participation in the study
排除标准
- •Patient already on ECT or aripiprazole.
- •History of psychoactive substance abuse or dependence.
- •Co-morbid psychiatric, major medical or neurological disorders.
- •History of organicity or significant head injury.
- •Pacemaker or metal in any body part, excluding the mouth. Pregnant and breastfeeding females.
研究组 & 干预措施
Maintenance ECT
干预措施: maintenance ECT (Procedure)
Aripiprazole
干预措施: Aripiprazole tablet (Drug)
结局指标
主要结局
Change in Positive And Negative Syndome Scale score
时间窗: Baseline, 6 weeks, 12 weeks, 24 weeks
Change from baseline in Total, Positive, negative and general scores with treatment. Minimum value: 30; maximum value: 210. Higher score means worsening of symptoms
次要结局
- Change in regional cerebral blood flow by the SPECT-CT brain(Baseline, 24 weeks)
- change in the Monteal Cognitive Assessment scores(Baseline,6 weeks, 12 weeks, 24 weeks)
- change in the Global Assessment of Functioning scores(Baseline, 6 weeks, 12 weeks, 24 weeks)
- Safety evaluation(Baseline,6 weeks, 12 weeks, 24 weeks)
研究者
BISWA RANJAN MISHRA
Additional Professor, Psychiatry
All India Institute of Medical Sciences, Bhubaneswar