Clinical Trial Comparing Two Electroconvulsive Therapy (ECT) Application Schemas in Ultra-resistant Schizophrenia
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 17
- 主要终点
- The response rate (a 30% decrease in the Positive and Negative Syndrome Scale (PANSS)) at 15th month
研究概览
简要总结
The effects of the ECT in schizophrenia ultra-resistant were studied in short times (4-6 months in most studies with follow-up). The literature identified a high relapse rate of 32% in the weeks to months after ECT discontinuation. The use of the ECT in the prevention of the relapse is partially known. In an empirical way, experts recommend protocols of prevention of the relapse going from 6 to 12 months. Nevertheless, the profit of a long cure (12 months) compared with a short cure (6 months) was never determined. Therefore, the investigators decided to lead a prospective randomized controlled study in order to compare the response rates between the two strategies of clozapine and ECT combinations applied to URS patients. The treatment consisted either in a short therapy of six months or a longer course of therapy of twelve months. To the investigators' knowledge, it is the first study which compares two ECT strategies (both the short duration and the longer one) for the treatment of URS patients.
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
- Single (Outcomes Assessor)
盲法说明
non-blinded treatment and blinded assessment
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with URS: patients who continue to experience persistent positive psychotic symptoms: item score of 4 (moderate) on at least two of four positive symptoms on the BPRS (grandiosity, suspiciousness, hallucinations and unusual thoughts), current presence of at least moderately severe illness on the total BPRS-18 (45) and a score of 4 (moderate) on the CGI-S, despite a period of clozapine therapy of at least 6 weeks with a plasma concentration of 350 ng/ml and at least two unsuccessful previous treatment trials with conventional or atypical antipsychotic drugs from two distinct families at a dose 600 mg of chlorpromazine equivalents.
- •Age: from 18 to 55
- •Patients with stable treatments for at least 8 weeks (antipsychotics, mood stabilizers and antidepressants).
- •Participants who gave their informed, written consents and agreement of their guardian for the patients under guardianship
- •Patients deprived of liberty if they gave their informed, written consents
排除标准
- •Current affective episode according to DSM-5 criteria;
- •ECT within (the last) 6 months;
- •Unstable epilepsy ; severe neurological or systemic disorder that could significantly affect cognition, behavior, or mental status (other than late dyskinesia or neuroleptic-induced parkinsonism);
- •Severe substance use disorders (other than nicotine or caffeine) according to DSM-5 criteria.
- •Concomitant use of antiepileptics and benzodiazepines apart from lamotrigine
- •Women of childbearing age with no adequate contraception, pregnant or lactating women;
- •Patients having contraindications to etomidate or any of its excipients;
- •Patients having contraindications to neuromuscular blocking agents;
- •Patients participating or having participated in an interventional clinical trial within 30 days prior to the inclusion visit;
结局指标
主要结局
The response rate (a 30% decrease in the Positive and Negative Syndrome Scale (PANSS)) at 15th month
时间窗: three months after the end of the treatment (i.e. 9 and 15 months)
The response rate (a 30% decrease in the PANSS, ranging from 30, the minimum, to 210, the most severe score) at 15th month
次要结局
- Neuropsychological assessment- test of doors(-1, 6 and 15 months)
- The response rate (a 30% decrease in the Brief Psychiatric Rating Scale (BPRS))(three months after the end of the treatment (i.e. 9 and 15 months))
- The response rate (a 30% decrease in the BPRS) at different times of the study(2, 4, 6 and 12 months)
- Response rate (a 30% decrease in the PANSS) at different times of the study(2, 4, 6 and 12 months)
- Neuropsychological assessment- MMSE(-1, 6 and 15 months)
- Neuropsychological assessment- SSTICS(-1, 6 and 15 months)
- Neuropsychological assessment- Grober and Buschke test(-1, 6 and 15 months)
- Neuropsychological assessment- test of d2(-1, 6 and 15 months)
- Neuropsychological assessment - "figure de Rey" test(-1, 6 and 15 months)
- Other clinical assessment- HAMD-21(day 1 and 2, 4, 6, 9, 12 and 15 months)
- Other clinical assessment-YMRS(day 1 and 2, 4, 6, 9, 12 and 15 months)
- Other clinical assessment-GAF(day 1 and 2, 4, 6, 9, 12 and 15 months)
- Other clinical assessment-MOAS(day 1 and 2, 4, 6, 9, 12 and 15 months)