Clinical TrialMajor Depressive Disorder (MDD)EsketaminePlaceboUnknown status

The Effectiveness and Safety of Esketamine in Modified Electroconvulsive Therapy

This parallel assignment, single-blind clinical trial (n=396) evaluates IV esketamine (0.25 mg/kg) versus saline prior to modified electroconvulsive therapy (MECT) for patients with severe depression.

Target Enrollment
396 participants
Study Type
Phase I interventional
Design
Randomized, single Blind

Detailed Description

Multicentre, randomised, single-blind, parallel-group trial comparing intravenous esketamine 0.25 mg/kg to saline control given before propofol/succinylcholine anaesthesia and MECT in patients with major depression (HDRS-24 ≥35).

Primary outcome is remission rate after MECT defined as two consecutive HDRS-24 scores ≤10. Sample size 396 (198 per arm) accounting for 20% dropout; allocation 1:1.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Esketamine 0.25 mg/kg

experimental

IV esketamine 0.25 mg/kg given prior to MECT with propofol and succinylcholine.

Interventions

  • Esketamine0.25 mg/kg
    via IV• single dose

    Given IV sequentially; co-administered propofol 1.5 mg/kg and succinylcholine 1 mg/kg prior to ECT.

Saline control

inactive

Saline 0.05 ml/kg given prior to MECT with propofol and succinylcholine (sham comparator).

Interventions

  • Placebo0.05 ml/kg
    via IV• single dose

    Normal saline 0.05 ml/kg; co-administered propofol 1.5 mg/kg and succinylcholine 1 mg/kg prior to ECT.

Participants

Ages
16 – 45
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Depressed patients receiving MECT for the first time;
  • 2. 16≤age≤45 years old, no gender limit;
  • 3. The ASA score is I or II;
  • 4. Meet the diagnostic criteria for depression established by APA, and the Hamilton Depression Rating Scale (HDRS-24) score ≥ 35 points;
  • 5. The depressive episode lasts at least 2 weeks;
  • 6. Clearly understand and voluntarily participate in the study, and sign an informed consent form.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Combined with serious physical diseases, such as uncontrolled hypertension, coronary heart disease, intracranial vascular malformations, asthma attacks, severe liver and kidney dysfunction, etc.;
  • 2. There are foreign bodies in the body: such as pacemakers, intracranial electrodes, etc.;
  • 3. Those with a history of epilepsy;
  • 4. Those who are taking reserpine;
  • 5. Acute and systemic infectious diseases, moderate or higher fever;
  • 6. History of manic episodes;
  • 7. Those who are allergic to anesthetics and muscle relaxants;
  • 8. Pregnant women;
  • 9. Glaucoma;
  • 10. Bipolar disorder, or other mental illnesses, mental retardation;
  • 11. Those who judged by the physician in charge to be unsuitable for MECT treatment;
  • 12. History of drug abuse.

Study Details

Locations

China

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