A 14-week, multicentre, double-blind, randomised, placebo-controlled phase II study with an 8-week treatment period to assess the efficacy and tolerability of a fixed dose of BH-200 (250 mg BID) in outpatients with Major Depressive Disorder (MDD)

Major Depressive Disorder

Change in the 17-item Hamilton Depression Rating Scale (HAMD-17) total score from baseline to visit 7.

Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to each planned post-baseline visit, where the MADRS is assessed (visit 5, visit 7 and visit 8 [follow-up visit])., Response rate (at least 50% reduction in the total score of HAMD-17 compared with baseline day 0) at each post-baseline visit., Remission rate (total score of HAMD-17 equal to or less than 7) at each post-baseline visit., Change in the HAMD-17 total score from baseline to each planned post-baseline visit., Change in the Clinical Global Impression-Severity of Illness rating scale (CGI-S) from baseline to each planned post-baseline visit., Change in the Hospital Anxiety and Depression Scale (HADS) total score, depressive sub-score, and anxiety sub-score from baseline to each planned post -baseline visit, Change in the 36-item Short Form Health Survey (SF-36, one-week recall version) from baseline to each planned post-baseline visit, where the SF-36 is assessed (visit 5, visit 7 and visit 8 [follow-up visit])., Change in the Sheehan Disability Scale (SDS) from baseline to each planned postbaseline visit, where the SDS is assessed (visit 5, visit 7 and visit 8 [follow-up visit])., Pharmacokinetic (PK) assessments., Change in suicidality, assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) from baseline to each planned post-baseline visit., Number of reported adverse events (AEs), serious AEs (SAEs), number of reported clinical safety abnormalities (safety laboratory, electrocardiogram [ECG]).

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