Clinical TrialParallelKetamineCompleted

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.

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

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Related paper: Right dorsolateral prefrontal cortex volumetric reduction is associated with antidepressant effect of low-dose ketamine infusion: A randomized, double-blind, midazolam-controlled PET-MRI clinical trialCompound research: Ketamine

Study Arms & Interventions

Ketamine 35 mg/70 kg

experimental

Single IV infusion of low-dose ketamine

Interventions

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

    Low-dose ketamine infusion

Midazolam 3.1 mg/70 kg (active comparator)

active comparator

Single IV infusion of midazolam

Interventions

  • Compound0.045 mg/kg
    via IV• single dose• 1 doses total

    Midazolam used as a control condition due to similar pharmacokinetic characteristics

Study Protocol, Arms & Participants

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Study Details

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

Related Publications

PaywallindividualPrimary

Right dorsolateral prefrontal cortex volumetric reduction is associated with antidepressant effect of low-dose ketamine infusion: A randomized, double-blind, midazolam-controlled PET-MRI clinical trial

This double-blind, randomised study (n=48) involving patients with treatment-resistant depression (TRD) and suicidal ideation (SI) evaluated the effects of a single infusion of 35mg/70kg ketamine or 3.15mg/70kg midazolam. Using positron emission tomography-magnetic resonance imaging, the study observed a small but significant volumetric reduction in the right dorsolateral prefrontal cortex (DLPFC) in the ketamine group compared to the midazolam group, and a greater reduction in depressive symptoms was associated with smaller decreases in right DLPFC volumes.

Published
Journal
Journal of Affective Disorders
Authors
Li, W. C., Chen, L. F., Su, T. P., Li, C. T., Lin, W. C., Wu, H. J., Tsai, S. J., Bai, Y. M., Tu, P. C., Chen, M. H.

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