Ketamine Autonomic / EEG Biomarkers in MDD: Pooled Czech Controlled Trials 2010–2015 (Meyer / Horacek / Novak, NIMH CZ)
Pooled secondary analysis of two Czech unregistered controlled ketamine infusion studies conducted 2010–2015 (Clin Neurophysiol 2021; Meyer T, Brunovsky M, Horacek J, Novak T, Andrashko V; National Institute of Mental Health / Charles University, Czech Republic; PMID 33888426). Total n=51 MDD inpatients across two studies; racemic IV ketamine 0.54 mg/kg administered over 30 min. Primary focus: autonomic nervous system responses (heart rate variability, sympatho-vagal balance) as predictors/mediators of antidepressant effect; EEG biomarkers also assessed. Study periods pooled: approximately 2010–2015 across two Prague-based sites. No CT.gov registration; no registration number reported in methods. CT.gov PMID reverse-lookup: 0 hits.
Study Arms & Interventions
Ketamine
experimentalSingle intravenous dose of racemic ketamine hydrochloride administered via infusion pump.
Interventions
- Ketamine0.54 mg/kgvia 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
placeboEqual amount of saline (sodium chloride 0.9%) solution administered via infusion pump.
Interventions
- Placebo nullvia IV• single dose• 1 doses total
Saline (0.9% NaCl) administered over the same time period as ketamine.
Primary Results(1 publication)
Participants
Adverse Events (from all publications)
| Arm / Group | n | Any TEAE | Severe | Serious | Discont. |
|---|---|---|---|---|---|
| Ketamineexperimental | 47 | 0(0.0%) | 0(0.0%) | 0(0.0%) | 0(0.0%) |
| Placeboplacebo | — | — | — | — | — |
* Safety data is pooled for the ketamine group (verum-cohorts) from two controlled trials (N=47 subjects). The paper explicitly states 'No unintended effects or important harms occurred in neither of the trials', indicating zero events for all categories.