Esketamine vs ECT for Acute Suicidality

NACompletedINTERVENTIONAL
Enrollment

340

Participants

Timeline

Start Date

April 16, 2024

Primary Completion Date

June 13, 2025

Study Completion Date

August 28, 2025

Conditions
Mood DisordersSuicidal IdeationDepressive 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.

Trial Locations (6)

100088

Beijing Anding Hospital, Beijing

241002

Wuhu Fourth People's Hospital, Wuhu

Unknown

Beijing Chaoyang District Third Hospital, Beijing

Beijing Daxing District Xinkang Hospital, Beijing

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

Inner Mongolia Autonomous Region Mental Health Center, Hohhot

All Listed Sponsors
collaborator

Wuhu Fourth People's Hospital

UNKNOWN

collaborator

The Second People's Hospital of Dali Bai Autonomous Prefecture

UNKNOWN

collaborator

Inner Mongolia Autonomous Region Mental Health Center

UNKNOWN

collaborator

Beijing Chaoyang District Third Hospital

UNKNOWN

collaborator

Beijing Daxing District Xinkang Hospital

UNKNOWN

lead

Capital Medical University

OTHER

NCT06355180 - Esketamine vs ECT for Acute Suicidality | Biotech Hunter | Biotech Hunter