Esketamine vs ECT for Acute Suicidality

Capital Medical University

Status: Completed

Conditions: Suicidal Ideation; Depressive Episode; Mood Disorders

Treatments: Drug: Esketamine; Device: Electroconvulsive therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06355180

Shoudufazhan2024-1-2122

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 340 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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340 participants in 2 patient groups

Intravenous esketamine

Experimental group

Description:

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.

Treatment:

Drug: Esketamine

Electroconvulsive therapy

Active Comparator group

Description:

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.

Treatment:

Device: Electroconvulsive therapy