Clinical TrialKetamineKetaminePlaceboPlaceboCompleted

Three-Arm Double-Blind RCT of Ketamine Dose in ECT Anaesthesia for TRD (Zhong 2016, China)

Three-arm double-blind RCT (J Affect Disord 2016; Zhong X, He H, Zhang C, Wang Z, Jiang M; single centre, China; PMID 27208499; April 2011 – April 2014). Participants: n=90 inpatients (30/group) with TRD meeting ICD-10 criteria for MDD or bipolar disorder; failed ≥2 antidepressants of different classes. Randomised to: (1) ketamine 0.8 mg/kg IV push, (2) ketamine 0.5 mg/kg + propofol 0.5 mg/kg IV, or (3) propofol 0.8 mg/kg IV (active control). All received bilateral ECT 3×/week for 3 weeks (8 sessions total, Thymatron System IV). Primary outcomes: HDRS-17 and BPRS-18 at baseline, after sessions 1–4, 6, and 8; cognitive battery (Word Fluency, Digit Span, WCST, TMT, Visual Reproduction) at baseline and 48–72h after final ECT. Response defined as ≥50% HDRS-17 reduction; remission as HDRS-17 ≤7. CT.gov: 0 hits; PubMed DataBankList: empty; no registration number in methods.

Target Enrollment
90 participants
Study Type
interventional
Design
Randomized, double Blind

Study Arms & Interventions

Ketamine

experimental

Ketamine (0.8 mg/kg) as an anesthetic for ECT

Interventions

  • Ketamine0.8 mg/kg
    via IV• single dose• 1 doses total

    Administered as an anesthetic for ECT sessions

Ketamine + Propofol

experimental

Subanesthetic ketamine (0.5 mg/kg) plus propofol (0.5 mg/kg) as anesthesia for ECT

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    Subanesthetic dose

  • Placebo0.5 mg/kg
    via IV• single dose• 1 doses total

    Used in combination with subanesthetic ketamine

Propofol

active comparator

Propofol (0.8 mg/kg) as an anesthetic for ECT

Interventions

  • Placebo0.8 mg/kg
    via IV• single dose• 1 doses total

    Used as the standard anesthetic comparator

Primary Results(1 publication)

Participants

N = 90Mean age: 29.2–32.1 across armsX. et al. 2016 →

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
Ketamineexperimental30—0(0.0%)0(0.0%)0(0.0%)
Ketamine + Propofolexperimental30—0(0.0%)0(0.0%)0(0.0%)
Propofolactive_comparator30—0(0.0%)0(0.0%)0(0.0%)

* No major adverse effects were observed. The majority of patients reported minimal transient adverse events (e.g., headaches and nausea) that remitted spontaneously and did not require discontinuation of ECT treatment. Specific counts for 'any' TEAEs are not provided.

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment90 participants
  • Timeline
    Start: 2011-04-01
    End: 2014-04-01
  • Compounds
    KetamineKetaminePlaceboPlacebo

Related Publications

Mood and neuropsychological effects of different doses of ketamine in electroconvulsive therapy for treatment-resistant depression

Published
Authors
Zhong, X., He, H., Zhang, C., Wang, Z., Jiang, M., Li, Q., Zhang, M., Huang, X.

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