Esketamine vs ECT for Acute Suicidality

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-16

Study Completion Date

2025-08-28

Brief Summary

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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.

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Detailed Description

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Suicide is a major global public health concern, yet current treatments for suicidal ideation (SI) remain limited in efficacy. This study evaluates whether a two-week course of six administrations of adjunctive intravenous esketamine is non-inferior to electroconvulsive therapy (ECT) in reducing SI among adults experiencing depressive episodes of mood disorders. This multicenter, randomized, non-inferiority, parallel-group trial will enroll 340 adults diagnosed with mood disorders with clinically significant SI during a depressive episode. Participants will be randomized in a 1:1 ratio to receive either six administrations of adjunctive intravenous esketamine or ECT over a two-week intervention period, followed by a 10-week observational follow-up phase (the total study duration will be 12 weeks). The primary outcome is the rate of remission of SI, defined as a Scale for Suicidal Ideation (SSI) score of less than 4, at the end of the two-week intervention. Secondary outcomes include comparative evaluations of treatment efficacy on depressive symptoms, cognitive function, quality of life, and social functioning, as well as safety. Exploratory outcomes include the identification of biomarker and neurobiological mechanisms of treatment response through analyses of biological specimens (blood, urine, and feces), multimodal magnetic resonance imaging (MRI), and electroencephalographic (EEG) measures.

Conditions

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Mood Disorders Suicidal Ideation Depressive Episode

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Intravenous esketamine

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.

Group Type EXPERIMENTAL

Esketamine

Intervention Type 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.

Electroconvulsive therapy

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.

Group Type ACTIVE_COMPARATOR

Electroconvulsive therapy

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Outpatients or inpatients aged 18 to 65 years (inclusive);
2. 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;
3. Having a total score of 6 or more on the SSI at screening;
4. Having at least primary school education and the ability to comprehend assessment scales;
5. Having provided written informed consent.

Exclusion Criteria

1. Having a current or historical diagnosis of neurodevelopmental, neurocognitive, psychotic, or substance-related disorders according to the DSM-5 criteria;
2. Having active delusions or hallucinations;
3. 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;
4. Being judged by the investigator as at risk for substance abuse or addiction;
5. Using reserpine currently;
6. Contraindications to general anesthesia;
7. Having a history of seizure disorders (except for uncomplicated childhood febrile seizures);
8. Having severe drug or food allergies or allergy to any component of the study medication;
9. Having a history of treatment non-response or severe adverse reactions to esketamine, ketamine, or ECT;
10. Having participated in any other clinical trials within the three months before the enrollment;
11. 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;
12. Being judged by researchers as unsuitable for participation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No