Single-group, open-label Phase II study (n=12) of IV ketamine infusions (0.3 mg/kg/hr over 100 minutes) given thrice-weekly for up to 2 weeks with weekly continuation x4 for remitters, in hospitalised adults with treatment-resistant depression and elevated suicide risk.
This single-arm, open-label trial evaluated intravenous ketamine delivered as an infusion at 0.3 mg/kg/hr over 100 minutes (approximately 0.5 mg/kg per infusion) in hospitalised adults with major depressive disorder or bipolar depression and elevated suicide risk. Acute treatment consisted of thrice-weekly infusions for up to two weeks; participants achieving remission at any acute visit entered a continuation phase of once-weekly infusions for four weeks and then had post-continuation follow-up visits.
Primary efficacy assessments used the Montgomery–Åsberg Depression Rating Scale (MADRS) with remission defined as MADRS total ≤9 24 hours after an infusion; suicidal ideation was monitored clinically and via the MADRS suicide item. Safety assessments included adverse events and standard clinical monitoring during and after infusions.
Single-group, two-phase intravenous ketamine treatment: acute-phase thrice-weekly infusions up to 2 weeks; remitters received once-weekly continuation x4.
Infusion rate 0.3 mg/kg/hr over 100 minutes (≈0.5 mg/kg total per infusion); continuation-phase weekly x4 for remitters; ketalar (brand).