Open-label, single-group Phase I study (n=21) testing transmucosal ketamine 0.5 mg/kg (two weekly doses) for treatment of post-stroke depression to assess feasibility, safety and exploratory antidepressant effects.
This open-label single-group study evaluates the feasibility and safety of transmucosal (sublingual) ketamine at 0.5 mg/kg administered twice, one week apart, in patients with post-stroke depression.
Primary aims are tolerability and feasibility; exploratory measures assess rapid antidepressant effects and safety signals to inform larger translational studies in the post-stroke population.
Open-label, single-group transmucosal ketamine 0.5 mg/kg administered beneath the tongue; two doses 1 week apart.
Place liquid beneath tongue, hold for 5 minutes; pharmacy prepares weight-based syringes.