Effects of Binaural Beat Music and Esketamine for ECT in the Treatment of Major Depressive Disorder: A Randomized Controlled Trial Protocol.

Major depressive disorder (MDD) is common and carries a high suicide risk. Electroconvulsive therapy (ECT) is highly effective but limited by adverse effects; ketamine/esketamine can boost ECT's efficacy and safety but have their own side effects. Binaural beat music (BBM), a non-invasive therapy, may improve mood and assist (es)ketamine. This 2×2 factorial, randomized, blinded clinical trial recruits 476 MDD patients requiring ECT, randomly assigned to four groups: blank sound with saline, blank sound with esketamine, BBM with saline, or BBM with esketamine. The primary outcome is response rate measured by the Hamilton depression scale; secondary outcomes include remission, suicidal ideation, cognitive function, and side effects. The data are expected to show BBM's potential for optimizing ECT strategies and improving patient outcomes.

Study at a glance

Abstract

Major depressive disorder (MDD) has a high incidence and high risk of suicide. Electroconvulsive therapy (ECT) is a highly effective and rapid physical therapy for MDD but limited by adverse effects. Ketamine/esketamine are new emerging rapid antidepressants, which can synergize the efficacy and safety of ECT but come with other side effects. Binaural beat music (BBM) is a non-invasive somatopsychic therapy with the potential to improve mood and assist the efficacy of (es)ketamine. Purpose of this study is to investigate the modification of BBM on effects of (esketamine combined with) ECT for MDD, and the probable interaction between BBM and esketamine, aiming to provide insights for optimizing ECT and improving outcomes of patients with MDD. This study is a 2×2 factorial, prospective, randomized, controlled, blinded clinical trial that recruiting 476 patients with MDD who require ECT treatments. These participants are randomly 1:1:1:1 allocated to the following groups (119 in each group): ① Group B0E0 (blank sound and normal saline); ② Group B0E1 (blank sound and esketamine); ③ Group B1E0 (BBM and normal saline); ④ group B1E1 (BBM and esketamine). The primary outcome is the response rate of patients to ECT treatment, assessed using the Hamilton depression scale (HAMD). Secondary outcomes include remission rate of depression and remission of suicidal ideation (assessed using HAMD), accompanied psychotic symptoms assessed using the Brief Psychiatric Rating Scale, cognitive function assessed using the Montreal Cognitive Assessment Scale, parameters of ECT, perianesthesia vital signs and anesthesia-related indices, blood biomarkers, and side effects. This study provides the first clinical evidence of the effects of BBM alone or interacted with esketamine in patients with MDD undergoing ECT. Our data are expected to suggest BBM's potential for developing better ECT therapeutic strategies, optimizing treatments for MDD and promoting prognosis.