EEG wakefulness regulation as a predictor of treatment response to oral prolonged-release ketamine (KET01) in patients with treatment resistant depression

Abstract

Approximately one third of depressed individuals do not adequately respond to several cycles of first-line antidepressant treatment. The non-competitive n-methyl-d-aspartate receptor antagonist ketamine has emerged as a promising alternative for treatment-resistant forms of depression (TRD). However, objective markers of response could not only lower treatment costs but could also significantly improve outcomes for these heavily afflicted patients by enabling targeted treatments. Recent studies by Meyer et al. (2021) and Ip et al. (in revision, translational psychiatry) provided evidence that specific patterns of wakefulness regulation derived from electrocardiogram and electroencephalography (EEG), respectively, could predict response to intravenous ketamine in major depression. Specifically, a higher percentage of EEG stage A1 – characterized by predominant alpha activity in occipital brain regions – at baseline was predictive of response. We aim to replicate this finding in an independent sample of 23 TRD patients and further explore the potential of EEG wakefulness regulation for prediction of treatment response to oral ketamine in comparison to intravenous ketamine. EEG recordings were conducted as part of a double-blind phase-2 randomized controlled trial for the effectiveness of oral-prolonged release racemic ketamine (KET01) in TRD. Patients were randomized to one of the following treatment arms: placebo, 160mg/d KET01, or 240mg/d KET01. The trail was pre-registered at the Swiss National Clinical Trials Portal under the trial number SNCTP000002938.

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