Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboCompleted

Ketamine Autonomic / EEG Biomarkers in MDD: Pooled Czech Controlled Trials 2010–2015 (Meyer / Horacek / Novak, NIMH CZ)

This unregistered trial (n=51) was a pooled analysis of two controlled ketamine infusion studies for major depressive disorder in inpatients, which found that heart rate and heart rate variability could serve as predictive biomarkers for treatment response.

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Target Enrollment
51 participants
Study Type
interventional
Design
Non-randomized

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 pooled data from two controlled trials conducted between 2010 and 2015 involving 51 inpatients with major depressive disorder. Participants received either a single intravenous infusion of racemic ketamine at a dose of 0.54 mg/kg or a saline placebo.

Researchers investigated the predictive and discriminative power of autonomic nervous system markers, specifically heart rate and heart rate variability, alongside EEG biomarkers. The analysis demonstrated that higher heart rates during the investigation period were associated with clinical response, suggesting these physiological measures may help optimise treatment selection for depression.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Single intravenous dose of racemic ketamine hydrochloride administered via infusion pump.

Interventions

  • Ketamine0.54 mg/kg
    via IV• single dose• 1 doses total

    Loading dose of 0.27 mg/kg for the first 10 min, followed by an infusion of 0.27 mg/kg within 20 min. Total dose 0.54 mg/kg within 30 min.

Placebo

placebo

Equal amount of saline (sodium chloride 0.9%) solution administered via infusion pump.

Interventions

  • Placebo null
    via IV• single dose• 1 doses total

    Saline (0.9% NaCl) administered over the same time period as ketamine.

Study Details

Related Publications

Open AccessindividualPooled analysis

Predictive value of heart rate in treatment of major depression with ketamine in two controlled trials

This open-label study (n=51) found that a large increase in heart rate (HR) and -variability (HRV) predicted better outcomes for those suffering from depression (MDD) after administration of ketamine.

Published
Journal
Clinical Neurophysiology
Authors
Meyer, T., Brunovský, M., Horacek, J., Andrashko, V., Seifritz, E., Olbrich, S.