The efficacy, safety and mechanism of esketamine... — Clinical Trial Details

The efficacy, safety and mechanism of esketamine vs electroconvulsive therapy in the treatment of suicidal risk of patients with major depressive episode

This Phase 4, parallel interventional trial in China (n=300) is comparing intravenous esketamine with modified electroconvulsive therapy (MECT) for patients with a major depressive episode and suicidal ideation. Participants are allocated to an esketamine group receiving intravenous infusion of esketamine 0.5 mg/kg or to an MECT group receiving MECT. The study includes adolescents and adults aged 13 to 85 years, with both sexes eligible. The primary outcome is change in suicidal ideation, assessed using the Beck Scale for Suicide Ideation. Secondary outcomes include depressive and anxiety symptoms, anhedonia, and dissociative effects, measured with the Montgomery–Åsberg Depression Rating Scale, Hamilton Depression Scale, Hamilton Anxiety Scale, Snaith-Hamilton Pleasure Scale, Dimensional Anhedonia Rating Scale, and the Clinician Administered Dissociative States Scale. The trial is designed to evaluate not only clinical efficacy and safety, but also potential mechanisms underlying the anti-suicidal effects of esketamine relative to MECT. Sponsored by The Affiliated Brain Hospital of Guangzhou Medical University, this study reflects ongoing clinical research in China into rapid-acting interventions for acute suicidal risk in major depressive episodes.

Participants

Ages

13 – 85

Sexes

Male & Female

BMI

Psychosis History

Inclusion Criteria

Inclusion criteria: 1. Aged 13-85 years old,right-handed, inpatient treatment at the Affiliated Brain Hospital of Guangzhou Medical University;2. Meet the diagnostic criteria for Major Depressive Disorder or bipolar disorder with Current or most recent episode depressed in the American Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV);3. HAMD-17 items = 17 points;4. Patients with current suicidal ideation, and the scores of item 4 or item 5 of Beck Scale for Suicide Ideation (SSI) = 2;5.Subjects with primary school education or above;6.The subjects who understand the content of the study are willing to join the study and sign the written informed consent.

Exclusion criteria: 1.Diagnosed with hypomanie episode or manic episode in 6 months, or the current YMRS >7 points;2.Diagnosed with other mental disorders diagnosed by DSM-4, including schizophrenia, substance related disorder and addiction disorder, autism spectrum dsorder, intellectual disabilities(except anxiety disorder);3.Patients with high suicide risk: had suicidal behavior (defined as self injuring behavior with intention to die) in the past six months, or the researchers judged that they had high suicide risk,or the answer of item 5 of a clinician-rated Columbia suicide severity rating scale (C-SSRS) ,whether they have suicidal ideation with specific plans and intentions,is yes;4.Refractory hypertension, hypothyroidism or hyperthyroidism, vitamin B12 or folic acid deficiency, syphilis infection;5.History of nervous system disease, like epilepsy, stroke, dementia, and brain trauma;6.Suffering from major physical diseases such as heart, lungs, liver, and kidney, and cannot tolerate this study;7.Past history of esketamine allergy;8.Patients with angle-closure glaucoma. 9.Bladder irritation symptoms (frequency of urination, urgency of urination, pain in urination) that require clinical intervention;10.Body mass index (BMI) < 17kg/m2 or > 40kg/m2;, or

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The efficacy, safety and mechanism of esketamine vs electroconvulsive therapy in the treatment of suicidal risk of patients with major depressive episode

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Sponsors & Collaborators