Effects of Binaural Beat Music and Esketamine for ECT in the Treatment of Major Depressive Disorder: A Randomized Controlled Trial Protocol.
Neuropsychiatric Disease and Treatment January 1, 2025 Ying Zhang, Zhaojuan Ke, Jie Luo et al. 3 citations
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.