Prospective observational cohort (n=80) comparing acute treatment courses of IV ketamine (0.5 mg/kg infusion) versus IN esketamine (56 mg then 84 mg) in adults with treatment-resistant major depressive disorder and suicidal ideation.
Multicentre prospective observational study collecting real-world clinical data on adult outpatients with MDD-TRD receiving either bi-weekly low‑dose IV ketamine infusions (0.5 mg/kg over 40 minutes) or intranasal esketamine (56 mg initial, 84 mg subsequent) for four weeks (eight sessions).
Clinical outcomes include MADRS change (primary), suicidal ideation (MADRS item 10), dissociation (CADSS-6), and tolerability (vital signs and adverse events); assessments occur at baseline and weekly through the acute series.
Study sites include Providence Care Hospital (Kingston, ON), Envision Mind Care (Edmonton, AB), CAMH (Toronto, ON), University of British Columbia (Vancouver, BC), and Sunnybrook Health Sciences Centre (Toronto, ON); treatment selection is clinical (insurance and patient preference influence modality).
Low-dose intravenous ketamine infusions given as standard-of-care.
0.5 mg/kg infusion over 40 minutes; observation post-infusion per clinic protocol.
Intranasal esketamine nasal spray given per approved dosing schedule.
56 mg first treatment, 84 mg for subsequent acute-series doses; ≥30 min observation post-dose.