Esketamine vs ECT for Acute Suicidality (NCT06355180) | Clinical Trial Compass
CompletedNot Applicable
Esketamine vs ECT for Acute Suicidality
China340 participantsStarted 2024-04-16
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;
✕
What they're measuring
1
Remission rate of suicidal ideation
Timeframe: Baseline, after the sixth treatments (week 2)