Clinical TrialKetamineCompleted

IV Ketamine Series for MDD/PTSD: Epigenetic Clock and DNA Methylation Study (Wild Health 2024, Lexington KY)

Open-label single-arm observational study (bioRxiv preprint 2024; Wild Health, Inc., Lexington, KY; DOI 10.1101/2024.09.10.24313258). Participants: n=20 adults with moderate-to-severe MDD and/or PTSD despite prior antidepressant treatment, recruited through Wild Health clinic. Intervention: 6 subanesthetic IV ketamine infusions (0.5 mg/kg each) over 2–3 weeks; 1 participant discontinued (adverse effects), yielding 19 completers (40 paired samples). Primary endpoints: peripheral blood DNA methylation profiling (Illumina EPIC BeadChip at TruDiagnostic Labs) including epigenetic clocks (DNAmPhenoAge, GrimAge, OMICmAge, DunedinPACE, SystemsAge) and EWAS. Secondary endpoints: PCL-5, PHQ-9, and 60 clinical laboratory tests (16 participants with complete paired lab data). No control arm; no randomisation; no clinical trial registration number in methods. CT.gov: 0 hits. PubMed DataBankList: empty.

Target Enrollment
20 participants
Study Type
interventional
Design
Non-randomized

Study Arms & Interventions

Ketamine infusion series

experimental

Six subanesthetic ketamine infusions over a 2-3 week treatment course.

Interventions

  • Ketamine0.5 mg/kg
    via IVsix infusions over 2-3 weeks6 doses total

    Subanesthetic dose

Primary Results(1 publication)

Participants

PCL-5

Score at Timepoint

Ketamine infusion series20.45Day 10·K. et al. 2024

PHQ-9

Score at Timepoint

Ketamine infusion series7.4Day 10·K. et al. 2024

OMICmAge

Score at Timepoint

Ketamine infusion series0Day 10·K. et al. 2024

GrimAge V2

Score at Timepoint

Ketamine infusion series0Day 10·K. et al. 2024

PhenoAge

Score at Timepoint

Ketamine infusion series0Day 10·K. et al. 2024

CD4 Memory T-cells

Score at Timepoint

Ketamine infusion series0.029Day 10·K. et al. 2024

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
Ketamine infusion seriesexperimental201(5.0%)

* One participant (out of 20) discontinued the ketamine infusions due to unspecified 'adverse effects'. No other summary data for total, severe, serious, or special interest adverse events were reported in the paper.

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment20 participants
  • Timeline
    Start: 2023-01-01
    End: 2024-01-01
  • Compound

Related Publications

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