Esketamine Treatment for Depressive Episodes With Suicidal Ideation in Mood Disorders

This multicenter, non-inferiority, randomized, parallel-group, open-label clinical trial (n=340) aims to evaluate the effectiveness of esketamine compared to modified electroconvulsive therapy (MECT) in treating suicidal ideation during depressive episodes of mood disorders.

Led by Dr. Gang Wang at Capital Medical University, the study addresses the urgent need for effective interventions to rapidly alleviate suicidal ideation (SI) in individuals with mood disorders.

Participants, aged 18 to 65, with SI during depressive episodes, will receive either subanesthetic dose intravenous esketamine or MECT. The primary outcome measure is the suicide remission rate based on the Scale for Suicidal Ideation (SSI). Secondary outcome measures include various scales assessing depression, cognition, and social function.

The study design is a randomized controlled trial with a phase IV intervention, aiming to provide evidence-based data for the clinical application of esketamine. Recruitment is estimated to have started in April 2024, with a primary completion date of December 2026.

Topic Depression Suicidality
Compound Ketamine
Country China
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 April 2024
End date 31 December 2026
Phase Phase IV
Design Blinded
Type Interventional
Generation First
Participants 340
Sex All
Age 18- 65
Therapy Yes

Trial Details

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.

Trial Number NCT06355180

Data attribution

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