Pilot double-blind randomized inpatient trial (n=9 actual) comparing IV ketamine (0.5 mg/kg) + TAU vs midazolam (0.045 mg/kg) + TAU, six infusions over two weeks, for reducing suicidal ideation in MDD and bipolar depression.
This double-blind, randomized, parallel-group pilot study tests whether repeated IV ketamine plus treatment as usual reduces suicidal ideation more than an active placebo (midazolam) plus treatment as usual in inpatients with major depressive disorder or bipolar depression.
Participants receive six infusions (0.5 mg/kg ketamine or 0.045 mg/kg midazolam) infused over ~40 minutes across two weeks; primary outcomes include SSI and C-SSRS at days 14 and 42, with MADRS and safety monitoring as secondary measures.
IV ketamine plus treatment as usual (TAU); six infusions over two weeks in depressed inpatients with suicidal ideation.
0.5 mg/kg infused over 40 minutes; infusion may be slowed up to 90 minutes if needed.
Treatment as usual (TAU) per site (antidepressant or mood stabiliser as clinically indicated).
Active placebo (midazolam) plus TAU; same schedule as ketamine.
Midazolam 0.045 mg/kg infused over 40 minutes (active placebo).
Treatment as usual (TAU).