Randomised, parallel, Phase IV study (n=45) comparing intranasal ketamine (50 mg split into 5 doses) versus IV ketamine (0.2 mg/kg) for Major Depressive Disorder.
This randomised, quadruple-blind, parallel-group trial compares intranasal ketamine (50 mg, delivered as five alternating-nostril doses) with IV ketamine (0.2 mg/kg IV push) in patients with Major Depressive Disorder and MADRS >20.
Patients failing to achieve response in the parallel phase may be offered an additional course of up to four 0.5 mg/kg ketamine infusions given twice weekly over two weeks (40-minute infusions). Primary outcome assessments include MADRS change; safety and tolerability monitored.
IV ketamine plus intranasal placebo (parallel design).
IV push 0.2 mg/kg; non-responders may be offered up to 4 additional 0.5 mg/kg infusions over 40 minutes.
Intranasal saline placebo 50 mg delivered as 5 doses alternating nostrils.
Intranasal ketamine plus IV placebo (parallel design).
Intranasal 50 mg delivered as 5 doses alternating nostrils; non-responders may be offered up to 4 additional 0.5 mg/kg IV infusions over 40 minutes.
IV saline placebo 0.2 mg/kg (IV push).