Relmada Therapeutics repors data from REL-1017-202 Phase 2 clinical study
Relmada Therapeutics reported top-line data from REL-1017-202, a double-blind, placebo-controlled Phase 2 clinical study evaluating the safety, tolerability and efficacy of two doses of REL-1017, 25 mg once a day and 50 mg once a day, as an adjunctive treatment in patients with treatment resistant depression. Subjects were adults with major depressive disorder (MDD) who did not respond to one to three courses of antidepressant treatment in their current episode. 62 subjects, average age 49.2 years, with an average Hamilton Depression Rating Scale score of 25.3 and an average Montgomery-Asberg Depression Rating Scale score of 34.0 (severe depression), were randomized. Other demographic characteristics were balanced across all arms. After an initial screening period, subjects were randomized to one of three arms: placebo, REL-1017 25 mg or REL-1017 50 mg, in addition to stable background antidepressant therapy. Subjects in the REL-1017 treatment arms received one loading dose of either 75 mg or 100 mg of REL-1017. 61 subjects received all treatment doses and were included in the per-protocol population treatment analysis; 57 subjects completed all visits. All 62 randomized subjects were part of the intention-to-treat population, or ITT, analysis. No differences were observed between the ITT and PPP analyses and results.