Efficacy of intranasal ketamine on acute suicidality, a double blind randomized placebo-controlled trial (Ketamine Trial Amsterdam, KETA)
Double-blind, randomised, placebo-controlled Phase II trial (n=128) testing a single 50 mg intranasal ketamine dose versus 4.5 mg intranasal midazolam to reduce acute suicidality in adults (18–70).
Details
This randomised double-blind Phase II trial compares a single intranasal 50 mg dose of ketamine (Ketalar) with 4.5 mg intranasal midazolam as an active placebo in adults presenting with acute suicidality; primary outcome is change in BSSI at 180 minutes post-dose.
Secondary outcomes include suicidality at 60 minutes, 1 day, 3 days and 1 week, depressive symptoms (MADRS), psychotomimetic symptoms (BPRS-PS), incidence of suicidal acts, biomarker analyses (BDNF, genetics) and neuroimaging (hippocampal MRS, DTI, fMRI). Blood samples are taken at baseline and 180 minutes.