Clinical TrialTreatment-Resistant Depression (TRD)KetamineEsketamineRecruiting

IV Ketamine Vs. in Esketamine for MDD TRD

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.

Target Enrollment
80 participants
Study Type
Phase NA observational
Design
Non-randomized

Detailed Description

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).

Study Protocol

Preparation

sessions

Dosing

8 sessions

Integration

sessions

Study Arms & Interventions

IV ketamine

experimental

Low-dose intravenous ketamine infusions given as standard-of-care.

Interventions

  • Ketamine0.5 mg/kg
    via IV• twice weekly• 8 doses total

    0.5 mg/kg infusion over 40 minutes; observation post-infusion per clinic protocol.

IN esketamine

active comparator

Intranasal esketamine nasal spray given per approved dosing schedule.

Interventions

  • Esketamine56 - 84 mg
    via Inhalation• twice weekly• 8 doses total

    56 mg first treatment, 84 mg for subsequent acute-series doses; ≥30 min observation post-dose.

Participants

Ages
18 – 75
Sexes
Male & Female

Inclusion Criteria

  • Adult outpatients (18-75 years old) with unipolar major depressive episodes (DSM-5) characterised as treatment-resistant depression (≥2 failed adequate antidepressant trials for current episode).
  • Participants are receiving standard-of-care treatment and agree to study assessments and informed consent.

Exclusion Criteria

  • Current psychosis; primary diagnosis of personality disorder; uncontrolled hypertension; substance abuse; currently pregnant or breastfeeding; previous adverse reaction to ketamine or esketamine; concurrent medications with significant interaction potential (benzodiazepines, naltrexone, lamotrigine, gabapentin, pregabalin) are discontinued per clinic protocol.

Study Details

Locations

Providence Care Hospital — Kingston, Ontario, Canada

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