Open-label, non-randomised Phase II study (n=40) of weekly supervised oral ketamine (start 0.5 mg/kg, titrate to 3.0 mg/kg) over six weeks for patients with chronic suicidal ideation.
This open-label Phase II study evaluates the efficacy, feasibility and tolerability of a supervised oral ketamine liquid formulation given once weekly for six weeks with psychiatrist-determined titration from 0.5 mg/kg to a maximum of 3.0 mg/kg.
Primary outcome is change in suicidality measured by the Beck Scale for Suicide Ideation (BSS). Secondary assessments include MRI and EEG at baseline, Week 6 and Week 10 to explore neural correlates and glutamatergic changes, plus safety monitoring (vitals, AEs, LFTs).
Weekly supervised oral sub-anaesthetic ketamine titrated over six weeks, administered at site under psychiatrist supervision with on-site monitoring.
Start 0.5 mg/kg and titrate 0.1–0.5 mg/kg weekly to 3.0 mg/kg per psychiatrist; supervised administration with ~1 h monitoring post-dose.
This open-label trial (n=30) examined the effects of weekly oral ketamine treatment over six weeks on functional recovery in adults with chronic suicidality. It finds that while depression and suicidality scores improved, effect sizes for social functioning and wellbeing were smaller, suggesting that symptom reduction alone may not restore full functioning.