Efficacy and feasibility of intranasal ketamine on acute suicidality, a double blind randomized placebo-controlled trial (Ketamine Trial for Acute suicidality, KETA)
Double-blind, randomized, placebo-controlled Phase II trial (n=112) testing a single 75 mg intranasal ketamine dose versus 4.0 mg intranasal midazolam in adults (18–70) with acute suicidality to assess anti‑suicidal efficacy and safety.
Details
Multicentre, randomized, double‑blind, placebo‑controlled trial assessing the anti‑suicidal effect of a single 75 mg intranasal ketamine dose compared with 4.0 mg intranasal midazolam in acutely suicidal adults.
Primary outcome is change in suicidality measured by the Beck Scale for Suicide Ideation (BSSI) from baseline to 180 minutes post‑dose; secondary measures include suicidality at additional timepoints, depressive symptoms (MADRS), psychotomimetic effects (CADSS, SAFTEE), CGI, and number of suicidal acts.
Ancillary investigations include neurobiological markers using MRI, MRS, DTI and fMRI, blood sampling and pharmacokinetic/pharmacogenetic assessments; safety and tolerability are monitored acutely and during follow‑up.