Esketamine vs ECT for Acute Suicidality

Summary

This study is a multicenter, randomized, non-inferiority, parallel-group clinical trial designed to evaluate the efficacy and safety of esketamine compared with electroconvulsive therapy (ECT) in the treatment of suicidal ideation during depressive episodes in patients with mood disorders. Furthermore, it aims to investigate the potential mechanisms underlying the anti-suicidal effects of esketamine.

Conditions

• Mood Disorders
• Suicidal Ideation
• Depressive Episode

Interventions

DRUG

Esketamine

The experimental group will receive intravenous esketamine hydrochloride. Participants will be asked to fast for 8 hours prior to administration. On treatment days, esketamine will be administered at a dose of 0.2 mg/kg, diluted in 0.9% sodium chloride solution. The infusion rate will be controlled with an infusion pump or syringe pump to ensure a minimum administration duration of 40 minutes. Treatment will be administered three times per week (the recommended interval between sessions is 1 to 2 days, adjustable based on clinical judgment) for two consecutive weeks, totaling six sessions. For participants demonstrating intolerance to either the dose of 0.2 mg/kg or the six-session regimen, investigators could modify the treatment protocol based on efficacy and safety assessments.

DEVICE

Electroconvulsive therapy

The control group will receive ECT. Prior to each session, participants will undergo safety evaluations and concomitant medication adjustments. Following an 8-hour fast and bladder evacuation, other preoperative preparations include intravenous administration of anticholinergic agents, short-acting anesthetics, and muscle relaxants. Electrodes will be placed unilaterally on the non-dominant hemisphere, with the seizure threshold determined via titration. The treatment will be administered three times per week (the recommended interval between sessions is 1 to 2 days, adjustable based on clinical judgment) for two consecutive weeks (six sessions in total). The protocol permitted regimen modifications for participants unable to tolerate the full course, based on efficacy and safety assessments.

Sponsors & Collaborators

• Wuhu Fourth People's Hospital

  collaborator UNKNOWN

• The Second People's Hospital of Dali Bai Autonomous Prefecture

  collaborator UNKNOWN

• Inner Mongolia Autonomous Region Mental Health Center

  collaborator UNKNOWN

• Beijing Chaoyang District Third Hospital

  collaborator UNKNOWN

• Beijing Daxing District Xinkang Hospital

  collaborator UNKNOWN

• Capital Medical University

  lead OTHER

Principal Investigators

• Gang Wang, MD · Beijing Anding Hospital, Capital Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-16

Primary Completion

2025-06-13

Completion

2025-08-28

Countries

• China

Study Locations