Esketamine Treatment for Depressive Episodes With Suicidal Ideation in Mood Disorders

Launched by CAPITAL MEDICAL UNIVERSITY · Apr 3, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how effective a treatment called esketamine is compared to a method known as modified electroconvulsive therapy (MECT) for people experiencing severe depression and thoughts of suicide. The study aims to see if esketamine can help reduce these suicidal thoughts during depressive episodes in individuals with mood disorders, such as Major Depressive Disorder or Bipolar Disorder.

To participate in this trial, individuals need to be between 18 and 65 years old and must currently have a significant depressive episode with suicidal thoughts. They should be able to understand the study materials and provide informed consent. Participants can expect to receive either esketamine or MECT, and the study will monitor their progress closely. It's important to note that some individuals, such as those with certain mental health conditions or severe health issues, may not be eligible to join. The trial is currently not recruiting participants, but it represents an important step in understanding better treatments for severe depression and suicidal thoughts.

Gender

ALL

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.