Clinical TrialKetaminePlaceboCompleted

Single IV Ketamine vs Midazolam for TRD with Suicidal Ideation: dPFC Volumetric RCT (Li WC / Su TP / Li CT, TVGH Taiwan)

Double-blind parallel RCT of single IV ketamine vs active midazolam control, with dPFC volumetric MRI as primary outcome (J Affect Disord 2023 Aug; Li WC, Chen LF, Su TP, Li CT, Lin WC et al.; Taipei Veterans General Hospital, Taiwan; PMID 37178823). n=48 randomised; participants: TRD (failed ≥2 adequate antidepressant trials) with active suicidal ideation; unipolar MDD. Intervention: single IV infusion of ketamine 0.5 mg/kg over 40 min vs midazolam 0.045 mg/kg active control. MRI-based dorsolateral/dorsal prefrontal cortex (dPFC/DLPFC) volumetric analysis at baseline and follow-up. MADRS, suicidal ideation scales as secondary outcomes. No CT.gov registration; no registration number reported in methods. CT.gov reverse-lookup (PMID, and author+condition search): 0 hits.

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

Study Arms & Interventions

Ketamine

experimental

Single IV infusion of low-dose ketamine

Interventions

  • Ketamine0.5 mg/kg
    via IVsingle dose1 doses total

    Low-dose ketamine infusion

Midazolam

active comparator

Single IV infusion of midazolam

Interventions

  • Placebo0.045 mg/kg
    via IVsingle dose1 doses total

    Midazolam used as a control condition due to similar pharmacokinetic characteristics

Primary Results(1 publication)

Participants

N = 48Mean age: 30.58–34.13 across armsC. et al. 2023

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
Ketamineexperimental24
Midazolamactive_comparator24

* No adverse event data was reported for this arm.

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment48 participants
  • Timeline
    Start: 2019-01-01
    End: 2022-12-31
  • Compounds

Related Publications

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