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CompletedNot applicable

Esketamine vs ECT for Acute Suicidality

NCT06355180 · Capital Medical University

Closed to entry
Status
Not accepting participants
Not applicable
Phase
340
Target enrolment
6
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Remission rate of suicidal ideation

    Measured over Baseline, after the sixth treatments (week 2)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria (all five criteria must be met for an individual to be included): 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 (an individual will be excluded if any one of the following criteria is met): 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.

Where

6 study sites

FacilityCityRegionCountry
Wuhu Fourth People's HospitalWuhuAnhuiChina
Beijing Anding HospitalBeijingBeijing MunicipalityChina
Beijing Chaoyang District Third HospitalBeijingChina
Beijing Daxing District Xinkang HospitalBeijingChina
The Second People's Hospital of Dali Bai Autonomous PrefectureDaliChina
Inner Mongolia Autonomous Region Mental Health CenterHohhotChina

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06355180 on ClinicalTrials.gov →

Last updated in the registry 2025-09-05. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits