University Department of Psychiatry, Centre d'Excellence Thérapeutique- Institut de Psychiatrie, Centre Hospitalier du Rouvray, Sotteville-lès-Rouen, France.
EPS Ville Evrard, Unité de Recherche Clinique, Neuilly-sur-Marne, France.
Trials. 2021 Apr 15;22(1):284. doi: 10.1186/s13063-021-05227-3.
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.
氯氮平是治疗耐药性精神分裂症最有效的抗精神病药物，但仍有 40%至 70%的患者疗效不佳或部分缓解。氯氮平联合电抽搐治疗（ECT）是治疗这些氯氮平耐药患者的一种非常有效且相对安全的治疗方法。然而，参数尚未得到很好的确定，例如最佳疗程数、疗程频率以及维持性 ECT 的相关性。我们的目的是比较两种氯氮平联合 ECT 治疗超耐药精神分裂症（URS）患者的疗效和耐受性：6 个月方案（20 次 ECT 疗程的短方案）和 12 个月方案（40 次 ECT 疗程的长方案）。
将纳入 64 例氯氮平治疗后持续存在精神病症状的精神分裂症患者，进行前瞻性、多中心、评估者设盲、随机对照试验。患者将被随机分配到短方案或长方案。主要结局是在长方案治疗结束后 3 个月，根据阳性和阴性症状量表（PANSS）评估的应答率与短方案相比。应答定义为 PANSS 基线下降 30%。临床评估（PANSS、BPRS、HAMD-21、YMRS、CGI、GAF、改良外显攻击量表（MOAS）和精神分裂症认知调查主观量表（SSTICS））和血浆氯氮平浓度将在基线时和 2、4、6、9、12 和 15 个月时进行。神经心理测量（MMSE、RL/RI-16、门测试、D2 注意力测试、复制 Rey-Osterrieth 复杂图形）将在基线时和 6 和 15 个月时进行。
本研究旨在优化 URS 患者氯氮平联合 ECT 的方案，并为这些患者的治疗提供具体建议。
ClinicalTrials.gov NCT03542903。于 2018 年 5 月 31 日注册。RCB 号：2017-A02657-46。
