This observational study (n=3) aims to observe the safety and tolerability of arketamine or placebo in patients with treatment-resistant depression (TRD) over a period of 12 months following their participation in a previous clinical trial (PCN-101-21).
Observational, comparative, retrospective study collecting quarterly (3, 6, 9, 12 months ±4 weeks) effectiveness and safety observations from patients who participated in the PCN-101-21 trial without altering their clinical care.
Background: reports suggest potential antidepressant effects of R-ketamine; this study aims to assess longer-term tolerability, safety and functional outcomes after intravenous R-ketamine or placebo exposure in a prior phase 2 trial.
Outcomes include disease exacerbations, hospitalisations, changes to psychotropic treatment, and functional impairment requiring social support; the study uses non-probability sampling and is retrospective.