Comparison of Maintenance ECT Versus Clozapine on Psychopathology and Cerebral Hemodynamics in Treatment-resistant Schizophrenia: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in severity of psychopathology
研究概览
简要总结
The proposed study will be conducted to compare the efficacy of maintenance ECT (M-ECT) vs Clozapine in treatment resistant schizophrenia (TRS) in terms of change in psychopathology measures and cerebral hemodynamics.
详细描述
The proposed study is a prospective, randomized clinical trial in patients suffering from treatment-resistant schizophrenia (TRS) and will be conducted in the Department of Psychiatry, AIIMS, Bhubaneswar, over a period of 16 months. Sixty patients with TRS (TRRIP consensus criteria, 2017), fulfilling the inclusion and exclusion criteria will be recruited for the study. Written informed consent will be taken after explaining the objectives and procedure of the study in detail. The detailed history, relevant social-demographic and clinical data will be collected in a structured case record form (CRF). At baseline, PANSS will be administered to determine the severity of positive symptoms, negative symptoms, and general psychopathology, Global assessment of functioning (GAF), and CGI to determine the baseline severity of the illness and improvement with treatment and MoCA to assess change in cognitive impairment. Before starting the treatment, brain SPECT-CT will be done to measure baseline regional brain blood perfusion. The study cohort will be randomized into two treatment groups by computer-generated random numbers, each group comprising 30 patients. One group will receive maintenance ECT (M-ECT) following acute treatment of bilateral ECT of six sessions along with ongoing antipsychotic and the other group will be treated with Clozapine monotherapy. PANSS, GAF, CGI, MoCA will be re-administered at 6 weeks, 3 months, and 6 months follow-up visits to compare the changes within each group and between the groups. Post-treatment SPECT-CT of the brain will be done at the end of 6 months to document changes in the regional cerebral blood perfusion.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients clinically diagnosed with treatment-resistant schizophrenia (TRS) (TRRIP consensus criteria).
- •Patients aged 18-60 years of either sex.
- •Patients giving voluntary written consent for participation in the study
排除标准
- •Patient already on Clozapine or ECT.
- •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 part of the body excluding the mouth.
- •Pregnant and breastfeeding females.
研究组 & 干预措施
Test group
Bilateral Maintenance ECT (B/L M-ECT)
干预措施: Bilateral M-ECT (Other)
Control group
Clozapine monotherapy. Clozapine will be given in accordance with Maudsley guideline: 12.5 mg on the first day, followed by 12.5mg twice daily on the second day, followed by 25mg twice daily for next two days and then increment of 25mg every two days till the target dose of 250-400 mg per day in two divided doses as per tolerability of the patients
干预措施: Clozapine (Drug)
结局指标
主要结局
Change in severity of psychopathology
时间窗: 24 weeks
Severity will be assessed by Positive and Negative Symptom Scale (PANSS) PANSS Score ranges from 30- 210. A higher score represents more severe psychopathology
次要结局
- Change in global functionality(24 weeks)
- Number of patients receiving rescue medications.(24 weeks)
- Change in regional cerebral blood flow(24 weeks)
- Change in illness severity, and global improvement with treatment(24 weeks)
- Change in Cognitive impairment(24 weeks)
研究者
BISWA RANJAN MISHRA
ADDITIONAL PROFESSOR
All India Institute of Medical Sciences, Bhubaneswar