Clinical TrialParallelTreatment-Resistant Depression (TRD)KetamineKetaminePlaceboCompleted

Dose-Related Effects of Single IV Ketamine Infusion in Treatment-Resistant Depression: A Randomised Parallel-Group Trial (Su 2017, Taipei Veterans General Hospital)

This unregistered trial (n=71) was a double-blind, placebo-controlled, randomised parallel-group study of single intravenous ketamine infusions for treatment-resistant depression in patients with recurrent major depressive disorder, which demonstrated significant dose-related antidepressant effects.

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Target Enrollment
74 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

This synthetic trial has been added to our database because a psychedelic paper (about a clinical trial) references this trial, but no (live) registration can be found.

The study investigated the dose-dependent antidepressant efficacy of a single intravenous infusion of R/S-ketamine (0.2 mg/kg and 0.5 mg/kg) compared to a saline placebo in a population of patients with treatment-resistant depression. Researchers specifically examined the influence of brain-derived neurotrophic factor (BDNF) genotypes on the clinical response.

Results indicated that both doses of ketamine led to significant reductions in Hamilton Depression Rating Scale (HAMD) scores compared to placebo. The responder analysis further confirmed a dose-related effect, with higher response rates observed in the 0.5 mg/kg group compared to the 0.2 mg/kg and placebo groups.

Study Arms & Interventions

0.5mg/kg Ketamine

experimental

Single 40 min intravenous infusion of R/S-ketamine hydrochloride at 0.5 mg/kg

Interventions

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

    R/S-ketamine hydrochloride

0.2mg/kg Ketamine

experimental

Single 40 min intravenous infusion of R/S-ketamine hydrochloride at 0.2 mg/kg

Interventions

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

    R/S-ketamine hydrochloride

Placebo (normal saline)

placebo

Single 40 min intravenous infusion of normal saline

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    Normal saline

Study Details

Locations

Taiwan

Related Publications

Open AccessindividualPrimary

Dose-Related Effects of Adjunctive Ketamine in Taiwanese Patients with Treatment-Resistant Depression

This double-blind, randomised, parallel-group, placebo-controlled trial study (n=71) examines adjunctive ketamine's dose-related effects in Taiwanese patients with treatment-resistant depression (TRD). This first such report showing the dose-related efficacy of ketamine for TRD, and characterized ketamine effects in a genotyped Chinese group in which 83% of patients had at least one copy of the BDNF gene's lower functioning Met allele.

Published
Journal
Neuropsychopharmacology
Authors
Su, T. P., Chen, M. H., Li, C. T., Lin, W. C., Hong, C. J., Gueorguieva, R., Tu, P. C., Bai, Y. M., Cheng, C. M., Krystal, J. H., Su, T. P.