Clinical TrialSuicidalityEsketaminePlaceboCompleted

Esketamine Treatment for Depressive Episodes With Suicidal Ideation in Mood Disorders

Multicentre, randomised, non-inferiority, parallel-group open-label trial (n=340) comparing six adjunctive IV esketamine infusions (0.2 mg/kg, 40-minute infusion, three times/week) versus six ECT sessions over two weeks for reduction of suicidal ideation in depressive episodes.

Target Enrollment
340 participants
Study Type
Phase NA interventional
Design
Randomized, single Blind

Detailed Description

This multicentre randomised non-inferiority trial will enrol 340 adults with depressive episodes and clinically significant suicidal ideation to compare adjunctive intravenous esketamine (six 0.2 mg/kg infusions over two weeks) with electroconvulsive therapy (six sessions over two weeks).

Primary outcome is remission of suicidal ideation (SSI <4) at end of the two-week intervention. Secondary and exploratory outcomes include depression severity, cognition, quality of life, social functioning, safety, and mechanistic biomarker assessments including blood/urine/feces analyses, multimodal MRI, and EEG.

Study Protocol

Preparation

sessions

Dosing

6 sessions
40 min each

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Intravenous esketamine

experimental

Six adjunctive IV esketamine infusions over two weeks (three times/week).

Interventions

  • Esketamine0.2 mg/kg
    via IV• three times per week• 6 doses total

    Infusion diluted in 0.9% NaCl; minimum infusion duration 40 minutes; fasting 8 hours prior.

Electroconvulsive therapy

active comparator

Six ECT sessions over two weeks (three times/week).

Interventions

  • Placebo
    via Other• three times per week• 6 doses total

    Electroconvulsive therapy (ECT) with unilateral electrode placement; anaesthesia and muscle relaxant per protocol; pre-session fasting and bladder evacuation.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion 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

  • 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 Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment340 participants
  • Timeline
    Start: 2024-04-01
    End: 2026-12-31
  • Compounds
    EsketaminePlacebo
  • Topic
    Suicidality

Locations

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

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