Double‑blind, randomised, parallel Phase III trial (n=100) comparing daily oral sub‑anesthetic ketamine for 21 days versus placebo in patients after a suicide attempt; includes fMRI mechanistic substudy and a healthy volunteer crossover (n≈40) with IV ketamine.
This is a randomized, triple‑blind, placebo‑controlled parallel trial evaluating daily oral sub‑anesthetic ketamine for 21 days versus oral placebo in patients admitted after a suicide attempt; primary aim is rapid reduction in suicidal ideation.
A subset of patient participants will undergo IV ketamine and fMRI before and after the first dose to probe mechanisms relating embodied self and emotion; outcomes include suicide and depression scales and neuroimaging measures.
A secondary healthy‑volunteer crossover (≈40 participants) will receive IV ketamine and IV saline in two sessions (1–6 weeks apart) with vRHI and pain perception tasks to investigate mechanistic effects.
Daily oral sub‑anesthetic ketamine for 21 days in patients after a suicide attempt; parallel randomised vs placebo; some subjects undergo IV/fMRI substudy.
Daily outpatient sub‑anesthetic oral ketamine for 21 days; dose per protocol (not specified here).
Daily oral placebo for 21 days (saline comparator).
Oral saline placebo for 21 days.
Daily oral ketamine for 21 days in treatment‑resistant depression subgroup.
Daily outpatient oral ketamine; dose per protocol (not specified here).
Daily oral placebo for 21 days in TRD subgroup.
Oral saline placebo.
Healthy participants (n≈40) crossover: IV ketamine vs IV saline in two sessions 1–6 weeks apart; vRHI and pain tasks with fMRI substudy.
IV ketamine; sessions separated 1–6 weeks; vRHI and pain tasks; mechanistic fMRI substudy.
IV saline comparator.