Clinical trial NCT06355180: Esketamine Treatment for Depressive Episodes With Suicidal Ideation in Mood Disorders
Official title: The Efficacy and Safety of Esketamine for Rapid Treatment of Depressive Episodes With Suicidal Ideation in Mood Disorders: A Multicenter, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Mood Disorders
Suicidal Ideation
Depressive Episode
Keywords: Esketamine
Depressive Episode
Suicidal Ideation
Mood Disorders
Multicenter
Randomized Controlled Study
MECT
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: Wuhu Fourth People's Hospital
name: The Second People's Hospital of Dali Bai Autonomous Prefecture
name: Inner Mongolia Autonomous Region Mental Health Center
name: Beijing Chaoyang District Third Hospital
name: Beijing Daxing District Xinkang Hospital
name: Capital's Funds for Health Improvement and Research
First posted: 2024-04-09
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, non-inferiority, randomized, parallel-group, open-label clinical trial aimed at evaluating the effectiveness of esketamine versus modified electroconvulsive therapy (MECT) in treating suicidal ideation during depressive episodes of mood disorders. Additionally, it seeks to explore the potential mechanisms of esketamine's anti-suicidal effects.

Detailed description: Suicide is a significant clinical and public health issue, with about 50% of individuals who die by suicide being diagnosed with a mood disorder within the year prior to their death, and 27% of suicide deaths attributable to depression. This indicates a higher risk of suicidal ideation (SI) during depressive episodes compared to the general population, highlighting the urgent need for effective interventions to rapidly alleviate SI and reduce suicide mortality rates. Currently, the rapid intervention measures for suicidal symptoms primarily include electroconvulsive therapy (ECT)/modified electroconvulsive therapy (MECT). However, due to the complexity of the procedures and certain risks involved, some institutions cannot perform this treatment. Additionally, cognitive impairments and other adverse reactions following the treatment may lead to patient noncompliance, thus there is a clinical urgency to find a simple, effective, and safe intervention to rapidly treat SI. Esketamine has been proven in past studies to have a rapid effect in relieving SI, but there is a lack of large-scale clinical studies to clarify the efficacy of esketamine due to short clinical observation periods. Therefore, there is an urgent need to conduct large-scale, multicenter RCT studies to verify whether esketamine is as applicable as ECT/MECT for rapid improvement of suicidal ideation in individuals with depressive episodes of mood disorders. This holds significant clinical importance and will provide key evidence-based foundations for future guidelines.

This study, through a randomized controlled trial, treats patients with suicidal ideation (SI) during depressive episodes of mood disorders using esketamine or modified electroconvulsive therapy (MECT). It compares the rapid anti-suicidal effects and adverse reactions of the two treatment modalities, providing evidence-based data for the clinical application of esketamine.

Eligibility criteria: Inclusion Criteria:

* Outpatients or inpatients, aged 18 to 65 years (inclusive of 18 and 65), regardless of gender;
* Current episode meets the diagnostic criteria for Major Depressive Disorder or Bipolar I or II disorder depressive episodes according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
* Total score of ≥6 on the Scale for Suicide Ideation (SSI);
* Educational level above primary school, able to understand the content of the scales;
* The patient has signed an informed consent form.

Exclusion Criteria:

* Current or past diagnosis of neurodevelopmental disorders, neurocognitive disorders, schizophrenia spectrum and other psychotic disorders, substance-related and addictive disorders according to DSM-5 standards;
* Presents with significant psychotic symptoms (delusions, hallucinations);
* Currently has severe or unstable conditions related to the central nervous system, cardiovascular system, respiratory system, liver, kidney, endocrine system, hematological system, or other systems deemed unsuitable for participation in this study by the researchers;
* Researchers deem there to be a potential risk of substance misuse and addiction;
* Currently taking medications containing thioridazine;
* Presence of risk factors for general anesthesia;
* History of seizure episodes (childhood simple febrile seizures without residual sequelae need not be excluded);
* History of severe drug or food allergies, or known allergy to components of the study medication;
* Previous ineffectiveness of esketamine/ketamine/ECT/MECT or occurrence of severe adverse reactions;
* Participation in other clinical trials within the last 3 months;
* Female subjects who are pregnant, nursing, planning a pregnancy during the study or within 12 weeks after the last dose of the study medication, or male subjects planning to father a child;
* Subjects deemed unsuitable for participation in this study by the researchers.

Primary outcomes:
measure: Suicide remission rate based on the Scale for Suicidal Ideation (SSI)
timeFrame: 12 weeks
Secondary outcomes:
measure: Quick Inventory of Depressive Symptoms Self Report (QIDS-SR)
timeFrame: 12 weeks
measure: Columbia Suicide Severity Rating Scale (CSSR-S)
timeFrame: 12 weeks
measure: Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: 12 weeks
measure: Clinical Global Impressions(CGI)
timeFrame: 12 weeks
measure: Short Form 12 Health Survey(SF-12)
timeFrame: 12 weeks
measure: Sheehan Disability Scale(SDS)
timeFrame: 12 weeks
measure: Digital Span Test(DST)
timeFrame: 12 weeks
measure: Digit Symbol Substitution Test(DSST)
timeFrame: 12 weeks
measure: Perceived Deficit Questionnaire for Depression 5-item(PDQ-D-5)
timeFrame: 12 weeks
measure: Young Mania Rating Scale (YMRS)
timeFrame: 12 weeks
measure: Clinician Administered Dissociative States Scale(CADSS)
timeFrame: 12 weeks
measure: Adverse event
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Anding Hospital, Capital Medical University
name: Gang Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: