CompletedN/Aketamine

Esketamine vs ECT for Acute Suicidality

Sponsored by Capital Medical University

NCT ID
NCT06355180
Target Enrollment
340 participants
Start Date
2024-04-16
Est. Completion
2025-08-28

About This Study

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.

Conditions Studied

Mood DisordersSuicidal IdeationDepressive Episode

Interventions

  • Esketamine
  • Electroconvulsive therapy

Eligibility

Age:18 Years - 65 Years
Healthy Volunteers:No
View full eligibility 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.

Study Locations (6)

Wuhu Fourth People's Hospital
Wuhu, Anhui, China
Beijing Anding Hospital
Beijing, Beijing Municipality, China
Beijing Chaoyang District Third Hospital
Beijing, China
Beijing Daxing District Xinkang Hospital
Beijing, China
The Second People's Hospital of Dali Bai Autonomous Prefecture
Dali, China
Inner Mongolia Autonomous Region Mental Health Center
Hohhot, China

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source

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