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An open-label clinical trial of oral ketamine, an NMDA (N-methyl-D-aspartate) receptor antagonist, with weekly dosing over six weeks, in 25-50 patients who are experiencing chronic suicidal ideation.

CompletedRegisteredANZCTR

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.

Details

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).

Topics:Suicidality

Registry

Registry linkACTRN12618001412224