Clinical TrialParallelKetamineKetaminePlaceboCompleted

Low-Dose Ketamine Effects on PFC and Amygdala in TRD: Double-Blind 3-Arm RCT with FDG-PET (Li CT / Su TP, TVGH Taiwan; UMIN000016985)

Double-blind, randomized, placebo-controlled 3-arm trial of low-dose IV ketamine in TRD with FDG-PET neuroimaging (Hum Brain Mapp 2016 Mar; Li CT, Chen MH, Lin WC, Hong CJ, Yang BH, Liu RS; Taipei Veterans General Hospital, Taiwan; PMID 26821769; DOI 10.1002/hbm.23085; UMIN000016985 confirmed via PubMed DataBankList). n=48 adults (aged 21–65) meeting DSM-IV-TR MDD criteria with TRD (failed ≥3 antidepressants including one during the current episode); background medications continued (add-on design). Randomised 1:1:1 to: Group A – ketamine 0.5 mg/kg IV over 40 min; Group B – ketamine 0.2 mg/kg IV over 40 min; Group C – normal saline. 16 subjects per arm. Primary outcome: FDG-PET-derived PFC and amygdala standardised uptake values (SUVs) pre- and post-infusion. HDRS-17 at baseline and 40/80/120/240 min post-infusion. Responder = ≥50% HDRS-17 reduction. BPRS positive subscale and side-effect monitoring for safety. UMIN000016985 registry confirmed.

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

Study Arms & Interventions

Ketamine 0.5mg/kg

experimental

40-min intravenous infusion of 0.5 mg/kg ketamine

Interventions

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

    40-min constant intravenous infusion

Ketamine 0.2mg/kg

experimental

40-min intravenous infusion of 0.2 mg/kg ketamine

Interventions

  • Ketamine0.2 mg/kg
    via IV• single dose• 1 doses total

    40-min constant intravenous infusion

Placebo

placebo

40-min intravenous infusion of normal saline

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    normal saline infusion

Study Protocol, Arms & Participants

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Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment48 participants
  • Timeline
    Start: 2013-01-01
    End: 2015-12-31
  • Compounds
    KetamineKetaminePlacebo

Related Publications

Open AccessindividualPrimary

The effects of low-dose ketamine on the prefrontal cortex and amygdala in treatment-resistant depression: A randomized controlled study

This double-blind placebo-controlled study (n=48) investigated the antidepressant efficacy of ketamine (14 or 35mg/70kg) in patients with depression and found evidence that its rapid antidepressant effects at 40 and 240 minutes post-treatment were facilitated by glutamatergic neurotransmission in the prefrontal cortex.

Published
Journal
Human Brain Mapping
Authors
Li, C. T., Chen, M. H., Lin, W. C., Hong, C. J., Yang, B. H., Liu, R. S., Tu, P. C., Su, T. P.

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