A double-blind randomized placebo-controlled trial to evaluate the efficacy and safety of electroconvulsive therapy in clozapine-resistant schizophrenia

• Grant number: 18/19927-0
• Support Opportunities: Regular Research Grants
• Start date: May 01, 2019
• End date: June 30, 2022
• Field of knowledge: Health Sciences - Medicine - Psychiatry
• Principal Investigator: Helio Elkis
• Grantee: Helio Elkis
• Host Institution: Instituto de Psiquiatria Doutor Antonio Carlos Pacheco e Silva (IPq). Hospital das Clínicas da Faculdade de Medicina da USP (HCFMUSP). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil
• City of the host institution: São Paulo

Abstract

It is estimated that at least 30% of patients taking clozapine do not respond adequately, maintaining high severity of symptoms, especially psychotic symptoms, and such patients are termed resistant to clozapine (CRS). Several clozapine augmentation strategies have been tested for such condition, particularly addition with antipsychotics, but none showed significant superiority over placebo. Despite the fact that electroconvulsive therapy (ECT) has been recommended for patients with CRS by the main international treatment guidelines of schizophrenia, the level of evidence for this recommendation is still low, since there are few controlled studies. In order to fill this gap, we conducted a pilot study with 20 patients whose goal was to potentiate clozapine with ECT compared to placebo (sham-ECT) and, after 12 sessions, we did not observe statistically significant differences between groups in terms of improvement of symptoms using the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression (CGI). (AU)

Scientific publications

(4)

(The scientific publications listed on this page originate from the Web of Science or SciELO databases. Their authors have cited FAPESP grant or fellowship project numbers awarded to Principal Investigators or Fellowship Recipients, whether or not they are among the authors. This information is collected automatically and retrieved directly from those bibliometric databases.)

ELKIS, HELIO; MELZER-RIBEIRO, DEBORA LUCIANA; NAPOLITANO, ISABEL CRISTINA; CORRELL, CHRISTOPH U.. The danger of averages in the context of heterogeneity: Response to the letter to the editor of SCZ RES- role of ECT in patients with CRS-Markota et al. 2024. SCHIZOPHRENIA RESEARCH, v. 269, p. 3-pg., 2024-05-19. (18/19927-0)

ELKIS, HELIO; CORRELL, CHRISTOPH U.; MELZER-RIBEIRO, DEBORA L.. Response to the Letter to the Editor " Reflections on a study of electroconvulsive therapy for clozapine-refractory schizophrenia" (Jolly et al. Schizophrenia Research, 267 (2024) 32-33). SCHIZOPHRENIA RESEARCH, v. 276, p. 2-pg., 2025-01-17. (18/19927-0)

MELZER-RIBEIRO, D. L.; NAPOLITANO, I. C.; LEITE, S. A.; DE SOUZA, J. A. ALENCAR; VIZZOTTO, A. D. B.; DI SARNO, E. S.; FORTES, M.; GOMES, M. L.; DE OLIVEIRA, G. M.; AVRICHIR, B. S.; et al. Randomized, double-blind, sham-controlled trial to evaluate the efficacy and tolerability of electroconvulsive therapy in patients with clozapine-resistant schizophrenia. SCHIZOPHRENIA RESEARCH, v. 268, p. 9-pg., 2024-06-11. (18/19927-0)

ELKIS, HELIO; MELZER-RIBEIRO, DEBORA LUCIANA; NAPOLITANO, ISABEL CRISTINA. Response to Markota et al. "Clinical heterogeneity and ECT in patients with clozapine resistant schizophrenia" SCHRES-D-24-00481. SCHIZOPHRENIA RESEARCH, v. 272, p. 2-pg., 2024-08-29. (18/19927-0)