Randomised, double-blind, crossover Phase III pilot (n=20) comparing IV esketamine (Ketanest S) versus active placebo (diphenhydramine) for negative and depressive symptoms in patients with schizophrenia-spectrum disorders.
Randomised, double-blind, two-period crossover trial in Austria (n=20) comparing IV esketamine (Ketanest S 25 mg/ml) with an active diphenhydramine placebo (Dibondrin) to assess efficacy on negative and depressive symptoms in schizophrenia-spectrum disorders.
Primary outcomes are change in the Scale for the Assessment of Negative Symptoms (SANS) and MADRS across treatment periods; secondary outcomes include PANSS, CDSS, CGI and CADSS with repeated assessments during and after each treatment period.
Esketamine (Ketanest S) IV treatment period of crossover design.
Ketanest S (esketamine) 25 mg/ml (2 ml ampoule); dosing per protocol in treatment period.
Active placebo comparator (diphenhydramine) given IV as crossover comparator.
Dibondrin (diphenhydramine hydrochloride, 15 mg/ml) used as active placebo; comparator described in protocol.