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

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)