ArticleThe world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry2026
Metabolomic correlates of intravenous racemic ketamine in treatment-resistant major depressive disorder: the Bio-K/NNDC multicenter trial.
Article in The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03156504 (The BIO-K Study), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The BIO-K Study: A Single-Arm, Open-Label, Biomarker Development Clinical Trial of Ketamine for Non-Psychotic Unipolar Major Depression and Bipolar I or II Depression.
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Authors and funding
12 authors.
Funding
Abstract
objectiveKetamine is a rapid-acting antidepressant with an incompletely understood mechanism of action. Pharmacometabolomics can identify pathways underlying its effects and response variability. Using data from the Bio-K trial (NCT03156504), a multisite open-label study, we characterised metabolomic signatures of intravenous (IV) racemic ketamine in adults with treatment-resistant depression (TRD).
methodsSixty-nine adults with TRD and major depressive disorder received three ketamine infusions (0.5 mg/kg). Remission was defined as MADRS ≤9 at 24 h post-third infusion. Metabolomic profiling used the Biocrates MxP® Q500 kit (>600 metabolites). Mixed-effects models assessed changes across time points (pre-dose, post-infusion 1, post-infusion 3), adjusting for age, sex, infusion length (first), and body mass index, with false discovery rate correction.
resultsMean MADRS improved from 27.8 ± 5.8 to 11.1 ± 9.1 post-third infusion (
conclusionsKetamine exposure was correlated with broad metabolic alterations spanning mitochondrial activation, neurotransmitter modulation, and neuroendocrine signalling. These findings represent metabolic correlates of ketamine exposure and remission, rather than validated predictors or established mechanistic drivers of antidepressant response.
trial registrationClinicalTrials.gov: NCT03156504.
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