A multicentre, double-blind, randomised, placebo-controlled phase II trial with a 3 week treatment period to assess the efficacy, safety and tolerability of add-on treatment with Ketamine hydrochloride prolonged release tablets (KET01, 120 mg or 240 mg once daily) in outpatients with treatment resistant depression
Randomised, double-blind, placebo-controlled Phase II trial (n=180 planned) assessing once-daily KET01 prolonged-release ketamine tablets (120 mg or 240 mg) versus placebo as add-on therapy in outpatients with treatment-resistant depression.
Details
Multicentre, double-blind, randomised parallel-group Phase II trial evaluating the efficacy and safety of KET01 120 mg or 240 mg once daily versus matched placebo as add-on treatment for subjects with treatment-resistant major depressive disorder.
Primary outcome is change in MADRS total score from baseline to end of treatment; secondary outcomes include response/remission rates, HAM-D17, CGI-S, quality of life measures, sleep indices, dissociation (CADSS), vital signs and population pharmacokinetics of ketamine and metabolites.