Brain Stimulation | 2021
The efficacy and acceptability of hybrid electroconvulsive therapy compared with standard electroconvulsive therapy for schizophrenia patients: A parallel-group, double-blind, randomized, controlled trial
Abstract
Previous studies have demonstrated that electroconvulsive therapy (ECT) augmentation of antipsychotics is highly effective for treatment-resistant schizophrenia patients or those who require a rapid response [1]. Despite the effectiveness of ECT, its use is limited primarily due to adverse events (AEs) [2,3], which may be related to ECT dosing, seizures or electrode placement [3,4]. Notably, a study demonstrated that nonconvulsive electrotherapy (NET) or low-charge electrotherapy (LCE) may have similar antidepressant effects to ECT but without serious AEs in a sample of patients with depression [5]. We conducted a pilot randomized controlled trial (RCT) and found that schizophrenia patients in the LCE group showed significantly fewer AEs compared with those in the ECT group [6]. However, our subsequent in-house data suggested that the initial remission may be slower in the LCE group than in the ECT group, and the patients in the LCE group required more treatment sessions. To combine the advantages of ECT (rapid remission) and LCE (fewer side effects), we designed a simple but novel energy set strategy for ECT, termed hybrid-ECT (HECT), for schizophrenia patients, in which the first four sessions use ECT (Phase 1) for rapid remission and the subsequent sessions use LCE (Phase 2) to reduce side effects, similar to the depression version [7]. To examine the efficacy and acceptability of HECT compared with standard ECT (all sessions were ECT) for schizophrenia patients, we performed the present RCT. This RCT was conducted at the Second People s Hospital of Huizhou in accordance with the Declaration of Helsinki (revised edition, 2008). The protocol was approved by the Human Ethics Committee of the Second People s Hospital of Huizhou. Written informed consent was obtained from all participants or their legal guardians. Patients or their legal guardians could withdraw at any time. The trial was registered in the Chinese Clinical Trial Registry (ChiCTR2000033507).