Article summary
This Phase II, randomised, quadruple-masked, parallel-group trial (n=200) will evaluate whether intramuscular (IM) ketamine combined with Crisis Response Planning (CRP) rapidly reduces suicidal thoughts in adults aged 18–70 presenting to an emergency department with acute suicidal ideation and anticipated inpatient admission. The primary outcome is change in the Depressive Symptoms Index–Suicidality Subscale at baseline, 24 hours and 28 days. Participants will be assigned to 1 of 4 groups: IM ketamine at 1 mg/kg plus a single 45–60-minute therapist-delivered CRP session; ketamine plus standard-of-care safety planning at discharge; saline placebo plus CRP; or placebo plus safety planning. Ketamine or placebo will be administered in the emergency department, with clinical monitoring for 1 hour, including assessment of vital signs, pulse oximetry and common ketamine side effects. Follow-up assessments will take place at 24 hours, 48 hours, 72 hours, 7 days, 28 days and 56 days, in pers...
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