Deicher Anton, Karl Sebastian, Otte Marie-Luise, Knabbe Johannes, Wendel Bernadette, Gose Maria, Wolf R Christian, Sartorius Alexander
Department of Psychiatry and Psychotherapy, Research Group Brain Stimulation, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, J5, 68159, Mannheim, Germany.
Department of General Psychiatry, Center for Psychosocial Medicine, Heidelberg University Hospital, Voßstraße 4, 69115, Heidelberg, Germany.
BMC Psychiatry. 2025 May 26;25(1):536. doi: 10.1186/s12888-025-06990-2.
Schizophrenia is one of the most severe and costly mental disorders in terms of human suffering and societal expenditure. About 15-30% of patients do not respond to all known antipsychotics, including clozapine, the current gold standard in these cases. Electroconvulsive therapy (ECT) is well-known to be highly effective in clozapine-treatment-resistant schizophrenia (CRS), and synergistic effects of clozapine and ECT have been demonstrated. However, relapse rates after successful courses of ECT are still very high, and evidence for maintenance ECT (mECT) in CRS is scarce at best.
Here, we present the protocol of the MECT-RESIST trial, a German multi-center, observer-blind, randomized, and actively controlled parallel-group clinical trial. The scientific aim of the study is to test the hypothesis that mECT plus treatment as usual (TAU) (intervention group) is superior to TAU alone (control group) for relapse prevention in CRS. The primary endpoint is time to relapse. Secondary endpoints include the proportion of relapse-free patients, the global level of functioning and quality of life, depressive symptoms, overall symptoms of schizophrenia, concomitant catatonic symptoms, stress and self-stigmatization and cognitive performance. We aim at randomizing 84 patients between 18 and 65 years with a clinically diagnosed CRS and brief psychotic rating scale (BPRS) > 45, who responded to a series of ECT (BPRS < 70% of initial BPRS), to either recieve mECT + TAU or TAU over a period of 28 weeks followed by a follow-up of 12 months. The study will be performed between 2025 and 2028.
In this multi-center trial, we aim to examine the effectiveness of mECT in CRS patients who improved after a course of routine ECT. If mECT will lead to a longer time to relapse and/or to a higher proportion of relapse-free patients compared to those undergoing treatment as usual, this trial would have an enormous impact on therapeutic strategies for patients with CRS and would induce a profound change of current treatment guidelines, where ECT still ranks at the level of ultima ratio, despite accumulating evidence suggesting otherwise.
ClincalTrials.gov NCT06456983, registered 7 Jun 2024. Deutsches Register Klinischer Studien DRKS00036886, registered 14 May 2025.
精神分裂症是人类痛苦和社会支出方面最严重且成本最高的精神障碍之一。约15%-30%的患者对所有已知抗精神病药物均无反应，包括氯氮平，而氯氮平是当前此类病例的金标准。众所周知，电休克疗法（ECT）对氯氮平治疗抵抗性精神分裂症（CRS）非常有效，并且已证明氯氮平和ECT具有协同作用。然而，ECT成功疗程后的复发率仍然很高，而关于CRS维持性ECT（mECT）的证据充其量也很稀少。
在此，我们展示了MECT-RESIST试验方案，这是一项德国多中心、观察者盲法、随机且积极对照的平行组临床试验。该研究的科学目的是检验以下假设：对于CRS复发预防，mECT加常规治疗（TAU）（干预组）优于单纯TAU（对照组）。主要终点是复发时间。次要终点包括无复发患者的比例、整体功能水平和生活质量、抑郁症状、精神分裂症的总体症状、伴随的紧张症症状、压力和自我污名化以及认知表现。我们旨在将84名年龄在18至65岁之间、临床诊断为CRS且简明精神病评定量表（BPRS）>45、对一系列ECT有反应（BPRS<初始BPRS的70%）的患者随机分为接受mECT + TAU或TAU治疗，为期28周，随后进行12个月的随访。该研究将于2025年至2028年进行。
在这项多中心试验中，我们旨在研究mECT对经过常规ECT疗程后病情改善的CRS患者的有效性。如果与接受常规治疗的患者相比，mECT能导致更长的复发时间和/或更高比例的无复发患者，那么该试验将对CRS患者的治疗策略产生巨大影响，并将引发当前治疗指南的深刻变革，尽管越来越多的证据表明并非如此，但在当前治疗指南中ECT仍处于最后手段的地位。
ClinicalTrials.gov NCT06456983，于2024年6月7日注册。德国临床试验注册中心DRKS00036886，于2025年5月14日注册。
