The efficacy, safety and mechanism of esketamine vs electroconvulsive therapy in the treatment of suicidal risk of patients with major depressive episode

This Phase 4, parallel interventional trial in China (n=300) is comparing intravenous esketamine with modified electroconvulsive therapy (MECT) for patients with a major depressive episode and suicidal ideation. Participants are allocated to an esketamine group receiving intravenous infusion of esketamine 0.5 mg/kg or to an MECT group receiving MECT. The study includes adolescents and adults aged 13 to 85 years, with both sexes eligible. The primary outcome is change in suicidal ideation, assessed using the Beck Scale for Suicide Ideation. Secondary outcomes include depressive and anxiety symptoms, anhedonia, and dissociative effects, measured with the Montgomery–Åsberg Depression Rating Scale, Hamilton Depression Scale, Hamilton Anxiety Scale, Snaith-Hamilton Pleasure Scale, Dimensional Anhedonia Rating Scale, and the Clinician Administered Dissociative States Scale. The trial is designed to evaluate not only clinical efficacy and safety, but also potential mechanisms underlying the anti-suicidal effects of esketamine relative to MECT. Sponsored by The Affiliated Brain Hospital of Guangzhou Medical University, this study reflects ongoing clinical research in China into rapid-acting interventions for acute suicidal risk in major depressive episodes.