The effect of intranasal ketamine on suicidality in severely depressed and suicidal patients. Randomized, placebo-controlled study
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.
Details
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.