PCORI Comparative Effectiveness Study-Esketamine (Spravato) Vs. Ketamine-Equivalence Study
Phase III, randomised, open-label, non-inferiority study (n=400) comparing IV racemic ketamine (up to 60 mg per infusion, max 8 lifetime doses) versus intranasal esketamine (56–84 mg per dose) for treatment-resistant depression.
Details
Multi-site, randomised, open-label, non-inferiority Phase III trial comparing intravenous racemic ketamine versus intranasal esketamine in patients with treatment-resistant depression; planned n=400, 1:1 allocation.
Primary outcomes are symptom improvement (effectiveness), acceptability, and tolerability; the study will also examine predictors of differential treatment response.
Ketamine administered as 40-minute IV infusions (max 60 mg per infusion, lifetime limit 8 doses); esketamine dosed per FDA label (56–84 mg) with allowance for dose reduction to 28 mg if needed.