Clinical TrialDepressive DisordersEsketaminePlaceboCompleted

Esketamine and Perioperative Depressive Symptoms

Randomised, double-arm (esketamine vs saline) parallel trial (n=435 actual) testing a single intra-operative IV esketamine infusion 0.2 mg/kg over 40 minutes to treat perioperative depressive symptoms in adults undergoing major surgery.

Target Enrollment
435 participants
Study Type
Phase II/III interventional
Design
Randomized, quadruple Blind

Detailed Description

This parallel, randomised, quadruple-masked trial evaluates the efficacy and safety of a single intra-operative intravenous esketamine infusion (0.2 mg/kg over 40 minutes) administered during wound closure for moderate to severe perioperative depressive symptoms in adults undergoing major elective surgery.

Secondary outcomes include anxiety, postoperative pain and broader psychiatric and safety assessments. Actual enrolled count of 435 is reported on the registry.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Esketamine

experimental

Single intra-operative IV esketamine infusion during wound closure (0.2 mg/kg over 40 minutes).

Interventions

  • Esketamine0.2 mg/kg
    via IV• single dose• 1 doses total

    Infused over 40 minutes during suturing/incision closure.

Placebo

inactive

Equivalent volume normal saline IV infusion during wound closure.

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    Normal saline, equivalent volume and infusion duration.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Patient undergoing elective major surgery
  • Ages between 18 and 65 years old
  • Moderate to severe depressive symptoms (the Patient Health Questionnaire-9 scores equal to or more than 10 and Montgomery-Åsberg Depression Rating Scale scores equal to or more than 22)
  • Signed informed consent

Exclusion Criteria

  • Exclusion Criteria:
  • Had aphasia or any conditions that prevented mental health assessments
  • Had a history of psychotic or bipolar disorder
  • Had a comorbidity that affected hormone levels
  • Required prolonged postoperative mechanical ventilation
  • Had received treatment with antidepressants within 2 weeks prior to the screening
  • Had a body mass index greater than 30 kg/m2 and a Child-Pugh score greater than 6 points
  • Had made repeated suicide attempts (as assessed by the 12-item Quick Inventory of Depressive Symptomatology scores less than 3)
  • Had experienced adverse reactions to ketamine or esketamine
  • Had known drug use disorders
  • Pregnant or breastfeeding

Study Details

  • Status
    Completed
  • Phase
    Phase IIPhase III
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment435 participants
  • Timeline
    Start: 2021-02-19
    End: 2023-12-31
  • Compounds
    EsketaminePlacebo
  • Topic
    Depressive Disorders

Locations

Beijing Tiantan Hospital, Capital Medical University — Beijing, China

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