Esketamine Treatment for Depressive Episodes With Suicidal Ideation in Mood Disorders

Suicidal Ideation Clinical Trial

Official title: The Efficacy and Safety of Esketamine for Rapid Treatment of Depressive Episodes With Suicidal Ideation in Mood Disorders: A Multicenter, Randomized Controlled Study

Status Not yet recruiting

Clinical Trial Summary

This study is a multicenter, non-inferiority, randomized, parallel-group, open-label clinical trial aimed at evaluating the effectiveness of esketamine versus modified electroconvulsive therapy (MECT) in treating suicidal ideation during depressive episodes of mood disorders. Additionally, it seeks to explore the potential mechanisms of esketamine's anti-suicidal effects.

Clinical Trial Description

Suicide is a significant clinical and public health issue, with about 50% of individuals who die by suicide being diagnosed with a mood disorder within the year prior to their death, and 27% of suicide deaths attributable to depression. This indicates a higher risk of suicidal ideation (SI) during depressive episodes compared to the general population, highlighting the urgent need for effective interventions to rapidly alleviate SI and reduce suicide mortality rates. Currently, the rapid intervention measures for suicidal symptoms primarily include electroconvulsive therapy (ECT)/modified electroconvulsive therapy (MECT). However, due to the complexity of the procedures and certain risks involved, some institutions cannot perform this treatment. Additionally, cognitive impairments and other adverse reactions following the treatment may lead to patient noncompliance, thus there is a clinical urgency to find a simple, effective, and safe intervention to rapidly treat SI. Esketamine has been proven in past studies to have a rapid effect in relieving SI, but there is a lack of large-scale clinical studies to clarify the efficacy of esketamine due to short clinical observation periods. Therefore, there is an urgent need to conduct large-scale, multicenter RCT studies to verify whether esketamine is as applicable as ECT/MECT for rapid improvement of suicidal ideation in individuals with depressive episodes of mood disorders. This holds significant clinical importance and will provide key evidence-based foundations for future guidelines. This study, through a randomized controlled trial, treats patients with suicidal ideation (SI) during depressive episodes of mood disorders using esketamine or modified electroconvulsive therapy (MECT). It compares the rapid anti-suicidal effects and adverse reactions of the two treatment modalities, providing evidence-based data for the clinical application of esketamine. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Episode
• Mood Disorders
• Suicidal Ideation

• NCT number: NCT06355180
• Study type: Interventional
• Source: Capital Medical University
• Contact: Gang Wang, MD
• Phone: +86 10 58340233
• Email: gangwangdoc@ccmu.edu.cn
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 2024
• Completion date: December 2026