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Clinical Trial
. 2025 Jul:350:112001.
doi: 10.1016/j.pscychresns.2025.112001. Epub 2025 May 23.

EEG vigilance and response to oral prolonged-release ketamine in treatment-resistant depression - A double-blind randomized validation study

Anna Monn  1 , Corinne Eicher  2 , Annia Rüesch  3 , Golo Kronenberg  4 , Benjamin Offenhammer  5 , Atalìa Adank  6 , Mateo de Bardeci  7 , Cheng-Teng Ip  8 , Hanne Scherer  9 , Linda Schaekel  10 , Michael Colla  11 , Annette B Brühl  12 , Erich Seifritz  13 , Sebastian Olbrich  14
Affiliations
Clinical Trial

EEG vigilance and response to oral prolonged-release ketamine in treatment-resistant depression - A double-blind randomized validation study

Anna Monn et al. Psychiatry Res Neuroimaging. 2025 Jul.

Abstract

Treatment-resistant depression (TRD) is associated with reduced quality of life and elevated mortality, posing a major challenge to psychiatric care. After non-response to conventional treatments, next-level interventions such as (es)ketamine are recommended, though remission rates remain variable. Identifying reliable markers of treatment response is therefore critical. Recent evidence suggests that a higher percentage of electroencephalography (EEG) vigilance stage A1 is associated with response to intravenous ketamine in major depression. We aimed to corroborate this finding in TRD patients from a recent phase-2 randomized controlled trial of oral prolonged-release ketamine. An algorithm classified vigilance stages in 21 10-minute resting-state EEG recordings. While no significant response × treatment interaction emerged for percentage of vigilance stage A1, a small-scale meta-analysis showed a significant pooled mean difference between ketamine responders and non-responders. Applying a previously proposed A1 cutoff (43 %) yielded chance-level prediction accuracy in the combined ketamine group, but 75 % accuracy in the 240 mg subgroup. Moreover, responders to 240 mg ketamine exhibited a significantly more stable vigilance over time compared to non-responders. Although further validation in a larger sample is warranted, these findings support the clinical value of EEG vigilance as a predictive biomarker for treatment outcomes in depression.

Keywords: Biomarker; EEG; Ketamine; Treatment-resistant depression.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Annette B. Bruehl reports financial support was provided by Ketabon GmbH. Erich Seifritz reports financial support was provided by Ketabon GmbH. Michael Colla reports financial support was provided by Ketabon GmbH. Sebastian Olbrich reports a relationship with Janssen and Schwabe Pharma that includes: consulting or advisory. Benjamin Offenhammer reports a relationship with Takeda Pharmaceutical Company Limited that includes: consulting or advisory. Michael Colla reports a relationship with Recordati, Sunovian, and Lundbeck that includes: consulting or advisory. Annette B. Bruehl reports a relationship with Janssen Schweiz that includes: board membership and consulting or advisory. Annette B. Bruehl reports a relationship with OM Pharma Ltd that includes: consulting or advisory. Annette B. Bruehl reports a relationship with Schwabe AG that includes: consulting or advisory. Erich Seifritz reports a relationship with Lundbeck Switzerland that includes: consulting or advisory, funding grants, paid expert testimony, and speaking and lecture fees. Erich Seifritz reports a relationship with Recordati Switzerland that includes: consulting or advisory, funding grants, and speaking and lecture fees. Erich Seifritz reports a relationship with Janssen Switzerland that includes: consulting or advisory, funding grants, paid expert testimony, and speaking and lecture fees. Erich Seifritz reports a relationship with Schwabe Switzerland & Germany that includes: consulting or advisory, funding grants, and speaking and lecture fees. Erich Seifritz reports a relationship with Takeda Switzerland that includes: consulting or advisory, funding grants, and speaking and lecture fees. Erich Seifritz reports a relationship with OM Pharma Switzerland that includes: consulting or advisory, funding grants, and speaking and lecture fees. Erich Seifritz reports a relationship with Sandoz Switzerland that includes: consulting or advisory, funding grants, and speaking and lecture fees. Erich Seifritz reports a relationship with Abcellera Canada that includes: equity or stocks. Sebastian Olbrich is co-founder of DeepPsy, but earns no money from DeepPsy. Erich Seifritz is co-author of the Swiss treatment guidelines for depression and anxiety disorders (unpaid). All remaining coauthors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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