Esketamine vs ECT for Acute Suicidality

NCT06355180 | Completed

• 1 other identifier: Shoudufazhan2024-1-2122
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Esketamine; Depressive Episode; Suicidal Ideation; Mood Disorders; Multicenter; Randomized Controlled Study; Electroconvulsive therapy

Outcome Measures

Primary Outcomes (1)

• Remission rate of suicidal ideation

  The Scale for Suicide Ideation (SSI) is a 19-item clinician-administered scale assessing the severity of suicidal ideation. Each item is scored from 0 to 2, yielding a total score ranging from 0 to 38, with higher scores indicating greater suicidal intent. The primary outcome is the rate of remission of suicidal ideation following the 2-week intervention (after 6 treatments), with the remission of suicidal ideation defined as having an SSI score of less than 4 (which indicates the absence of clinically significant suicidal ideation).

  Baseline, after the sixth treatments (week 2)

Secondary Outcomes (20)

• Remission rate of suicidal ideation

  Baseline, after the first treatment, after the third treatment, at week 4, week 8, and week 12

• Rates of sustained remission and recurrence of suicide ideation

  Baseline, after the first treatment, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12

• Changes in SSI Scores

  Baseline, after the first treatment, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12

• Changes in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores

  Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12

• Response rate of depressive symptoms

  Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12

Study Arms (2)

Intravenous esketamine

EXPERIMENTAL

The experimental group will receive six administrations of adjunctive intravenous esketamine over a two-week intervention period, followed by a 10-week observational follow-up phase.

Drug: Esketamine

Electroconvulsive therapy

ACTIVE COMPARATOR

The control group will receive six administrations of adjunctive ECT over a two-week intervention period, followed by a 10-week observational follow-up phase.

Device: Electroconvulsive therapy

Interventions

Esketamine DRUG

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.

Intravenous esketamine

Electroconvulsive therapy DEVICE

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.

Electroconvulsive therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients or inpatients aged 18 to 65 years (inclusive);
• Having a current diagnosis of MDD or depressive episode in bipolar I/II disorder, established using the Mini-International Neuropsychiatric Interview, version 7.0.2 (MINI 7.0.2) and according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria;
• Having a total score of 6 or more on the SSI at screening;
• Having at least primary school education and the ability to comprehend assessment scales;
• Having provided written informed consent.

You may not qualify if:

• Having a current or historical diagnosis of neurodevelopmental, neurocognitive, psychotic, or substance-related disorders according to the DSM-5 criteria;
• Having active delusions or hallucinations;
• Suffering from severe/unstable systemic illness (illness affecting the central nervous system, cardiovascular, respiratory, hepatic, renal, endocrine, or hematologic systems) and judged by the investigator as unsuitable for participation;
• Being judged by the investigator as at risk for substance abuse or addiction;
• Using reserpine currently;
• Contraindications to general anesthesia;
• Having a history of seizure disorders (except for uncomplicated childhood febrile seizures);
• Having severe drug or food allergies or allergy to any component of the study medication;
• Having a history of treatment non-response or severe adverse reactions to esketamine, ketamine, or ECT;
• Having participated in any other clinical trials within the three months before the enrollment;
• Being pregnant, breastfeeding, or planning to become pregnant (for female participants) or planning to father a child (for male participants) during the study or within 12 weeks after the last dose of medication;
• Being judged by researchers as unsuitable for participation.

Sponsors & Collaborators

• Capital Medical University: lead
• Wuhu Fourth People's Hospital: collaborator
• The Second People's Hospital of Dali Bai Autonomous Prefecture: collaborator
• Inner Mongolia Autonomous Region Mental Health Center: collaborator
• Beijing Chaoyang District Third Hospital: collaborator
• Beijing Daxing District Xinkang Hospital: collaborator

Study Sites (6)

Wuhu Fourth People's Hospital

Wuhu, Anhui, 241002, China

Location

Beijing Anding Hospital

Beijing, Beijing Municipality, 100088, China

Location

Beijing Chaoyang District Third Hospital

Beijing, China

Location

Beijing Daxing District Xinkang Hospital

Beijing, China

Location

The Second People's Hospital of Dali Bai Autonomous Prefecture

Dali, China

Location

Inner Mongolia Autonomous Region Mental Health Center

Hohhot, China

Location

MeSH Terms

Conditions

Mood Disorders; Suicidal Ideation

Interventions

Esketamine

Condition Hierarchy (Ancestors)

Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Gang Wang, MD

  Beijing Anding Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It is not feasible to blind participants and caregivers due to the distinct nature of the interventions. Outcome assessors (independent evaluators responsible for primary and secondary outcomes, such as SI and depression severity scores) and data analysts (personnel conducting statistical analyses) will remain blinded to group assignments through the use of randomized, coded data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Beijing Anding Hospital, Capital Medical University

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 9, 2024
• Study Start: April 16, 2024
• Primary Completion: June 13, 2025
• Study Completion: August 28, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)