Clinical TrialMajor Depressive Disorder (MDD)PlaceboPlaceboKetaminePlaceboEsketaminePlaceboUnknown status

The Effect of S-ketamine for Patients Undergoing Electroconvulsive Therapy (ECT)

Randomised, quadruple-blind, factorial trial (n=150) comparing S-ketamine 0.25 mg/kg and ketamine 0.5 mg/kg versus propofol+saline during ECT in adults with depressive disorders to evaluate short-term efficacy and safety.

Target Enrollment
150 participants
Study Type
Phase NA interventional
Design
Randomized, quadruple Blind

Detailed Description

This randomised, quadruple-blind, factorial study (n=150) evaluates whether adjunctive intravenous S-ketamine (0.25 mg/kg) or ketamine (0.5 mg/kg), given with propofol anaesthesia, improves short-term antidepressant outcomes and safety during routine ECT for adults with depressive disorders.

Primary outcomes focus on short-term efficacy and safety; secondary assessments include cognitive effects, adverse events, and measures relevant to suicide risk and relapse.

Interventions compare three arms: propofol+saline (placebo comparator), propofol+ketamine (0.5 mg/kg), and propofol+S-ketamine (0.25 mg/kg), administered as IV bolus infusions prior to ECT sessions.

Study Arms & Interventions

Propofol

inactive

Propofol 1 mg/kg plus saline bolus infusion before ECT (placebo comparator arm).

Interventions

  • Placebo1 mg/kg
    via IV• single dose

    Propofol 1 mg/kg IV bolus + saline bolus infusion before ECT

  • Placebo
    via IV• single dose

    Saline bolus infusion (placebo)

Ketamine

active comparator

Propofol 1 mg/kg plus ketamine 0.5 mg/kg bolus infusion before ECT (active comparator).

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose

    Ketamine 0.5 mg/kg IV bolus before ECT

  • Placebo1 mg/kg
    via IV• single dose

    Propofol 1 mg/kg IV bolus (co-administered)

S-ketamine

experimental

Propofol 1 mg/kg plus S-ketamine 0.25 mg/kg bolus infusion before ECT (experimental).

Interventions

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

    S-ketamine (esketamine) 0.25 mg/kg IV bolus before ECT

  • Placebo1 mg/kg
    via IV• single dose

    Propofol 1 mg/kg IV bolus (co-administered)

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • American Society of Anesthesiologists (ASA) Physical Status I-II
  • Diagnosis of depressive disorder by DSM-IV
  • Without cognitive impairment
  • No ECT in past 6 months

Exclusion Criteria

  • Exclusion Criteria:
  • Other comorbid psychiatric diagnoses, including schizophrenia, mania
  • Organic heart diseases, severe hypertension and arrhythmia
  • Severe hepatic and renal diseases
  • Severe cerebrovascular disorder or malformation, intracranial mass lesions and seizure
  • Glaucoma or high intraocular pressure and intra-ocular pathology
  • Severe haematological disease, fracture and obesity, pregnancy
  • Severe respiratory tract disease or difficult ventilation or intubation
  • Pre-existing neurological disease or cognitive impairment
  • Allergy to anesthetics
  • Drug abuse or alcohol addiction
  • Family history of malignant hyperthermia
  • Refuse to participate or inability to understand study questionnaires; recent participation in other clinical trials

Study Details

Locations

West China Hospital of Sichuan University, Department of Anesthesiology — Chengdu, Sichuan, China

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