This Phase IV, randomised, double-blind, placebo-controlled, parallel-group trial (n=72) evaluated intranasal ketamine vs placebo for suicidality in patients with severe major depression awaiting ECT.
Randomised, double-blind, parallel two-arm trial in Finland testing intranasal ketamine (Ketalar formulation at 50 mg/ml concentration reported) against a nasal-spray placebo in severely depressed patients with significant suicidality who were awaiting ECT.
Primary endpoint was a reduction of at least six points on the SSI scale measured one day after treatment. The trial was authorised by the Finnish competent authority and favourable ethics opinion was recorded, but the global end of trial status is reported as 'Prematurely Ended' with a global end date of 2018-12-31.
Intranasal ketamine (marketed Ketalar formulation repurposed for intranasal use) vs placebo in parallel-group design.
Intranasal administration; formulation concentration recorded as 50 mg/ml in trial record; exact per-dose mg not specified.
Placebo nasal spray (single-dose container)
Nasal spray placebo, single-dose container as described in EudraCT record.