A prospective multicenter assessor-blinded randomized controlled study to compare the efficacy of short versus long protocols of electroconvulsive therapy as an augmentation strategy to clozapine in patients with ultra-resistant schizophrenia (SURECT study).
A prospective multicenter assessor-blinded randomized controlled study to compare the efficacy of short versus long protocols of electroconvulsive therapy as an augmentation strategy to clozapine in patients with ultra-resistant schizophrenia (SURECT study).
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一项前瞻性、多中心、评估者设盲、随机对照研究，旨在比较短方案与长方案电休克治疗作为超耐药精神分裂症患者氯氮平强化策略的疗效（SURECT研究）。
DOI：
10.1186/s13063-021-05227-3
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发表时间：
2021-04-15
期刊：
影响因子：
2.5
通讯作者：
Rothärmel M
中科院分区：
文献类型：
--
作者：
Moulier V;Krir MW;Dalmont M;SURECT Group;Guillin O;Rothärmel M
虽然氯氮平是治疗难治性精神分裂症最有效的抗精神病药物，但40%至70%的患者对氯氮平的反应较差或部分有效。对于这些对氯氮平耐药的患者来说，电休克治疗(ECT)是一种高效且相对安全的治疗方法。然而，参数还没有很好地指定，例如最优会话数量、它们的频率以及维护ECT的相关性。我们的目的是比较ECT和氯氮平联合治疗超难治性精神分裂症(URS)患者的两种方案的疗效和耐受性：6个月方案(短方案，20次ECT)和12个月方案(长方案，40次ECT)。64名尽管接受氯氮平治疗但仍有持续精神症状的精神分裂症患者将参加一项前瞻性多中心评估者盲法随机对照试验。患者将被随机分配到短期或长期方案。主要结果是通过阳性和阴性症状量表(PANSS)在治疗结束3个月后评估长期方案与短期方案患者的应答率。应答被定义为在PANSS基线上减少30%。分别于治疗前、治疗后2、4、6、9、12和15个月进行临床评估(PANSS、简明精神病评定量表、HAMD-21、YMRS、CGI、GAF、修订的外显攻击量表和主观精神分裂症认知评定量表)和氯氮平血药浓度的测定，并与对照组比较。 组治疗后2个月、4个月、6个月、9个月、12个月、15个月氯氮平血药浓度。神经心理测试(MMSE、RL/RI-16、DOORS测试、D2注意力测试、Rey-Osterrieth复杂图形复制)将在基线、6个月和15个 时进行。本研究的目的是优化ECT联合氯氮平治疗尿路综合征患者的方案，并为这些患者的护理提供具体的建议。临床试验.gov NCT03542903。注册日期为2018年5月31日。ID RCB：2017-A02657-46
Although clozapine is the most effective antipsychotic drug for treatment-resistant schizophrenia, it leads to a poor or partial response in 40 to 70% of patients. Augmentation of clozapine with electroconvulsive therapy (ECT) is a highly effective and relatively safe treatment for these clozapine-resistant patients. However, parameters are not yet well specified, such as the optimal number of sessions, their frequency, and the relevance of maintenance ECT. Our objective is to compare the efficacy and tolerance between two protocols of combined ECT and clozapine treatment in patients with ultra-resistant schizophrenia (URS): a 6-month protocol (short protocol with 20 ECT sessions) and a 12-month protocol (long protocol with 40 ECT sessions). Sixty-four patients with schizophrenia with persistent psychotic symptoms despite clozapine treatment will be enrolled in a prospective multicentric assessor-blinded randomized controlled trial. Patients will be randomly assigned to the short or the long protocol. The main outcome is the response rate assessed by the Positive and Negative Symptoms Scale (PANSS) 3 months after the end of the treatment in patients following the long protocol compared to those following the short protocol. The response was defined as a 30% reduction on the PANSS baseline. Clinical assessments (PANSS, BPRS, HAMD-21, YMRS, CGI, GAF, Modified Overt Aggression Scale (MOAS), and Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS)) and plasma clozapine concentration will be performed at baseline and at 2, 4, 6, 9, 12, and 15 months. Neuropsychological measures (MMSE, RL/RI-16, Doors test, D2 Test of Attention, Copy of the Rey-Osterrieth complex figure) will be performed at baseline and at 6 and 15 months. The aims of this research are to optimize protocols of combined ECT with clozapine in patients with URS and to offer specific recommendations for these patients’ care. ClinicalTrials.gov NCT03542903. Registered on May 31, 2018. Id RCB: 2017-A02657-46
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影响因子：
5.3
作者：
Coccaro, Emil F.;Lee, Royce J.;Kavoussi, Richard J.
通讯作者：
Kavoussi, Richard J.
DOI：
10.1159/000497376
发表时间：
2019-04-01
期刊：
Molecular neuropsychiatry
影响因子：
--
作者：
Ali, Sana A;Mathur, Nandita;Braga, Raphael J
通讯作者：
Braga, Raphael J
影响因子：
1.9
作者：
BELL, M;MILSTEIN, R;CICCHETTI, D
通讯作者：
CICCHETTI, D
DOI：
10.1016/j.pnpbp.2015.08.010
发表时间：
2016-02-04
影响因子：
5.6
作者：
Iasevoli, Felice;Giordano, Sara;de Bartolomeis, Andrea
通讯作者：
de Bartolomeis, Andrea
影响因子：
3.1
作者：
Hasan, Alkomiet;Falkai, Peter;Moeller, Hans-Juergen
通讯作者：
Moeller, Hans-Juergen