A Study of MD-120 in Patients With Depression

A Placebo-controlled Study of MD-120 in Patients With Depression

The purpose of this study is to verify the efficacy and evaluate the safety of 8-week once-daily oral administration of MD-120 in Japanese patients with depression.

Inclusion Criteria:

• Patient with diagnosis of Major Depressive Disorder (MDD) based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5).
• Hamilton Depression Rating Scale-17 (HAM-D17) total score of ≥20.

Exclusion Criteria:

• Patient who meets DSM-5 criteria of the following disorders for current or past history.

Schizophrenia spectrum and other psychotic disorders Bipolar and related disorders Substance use disorders (exclusive of tobacco and caffeine)

• Patient who had suicidal behavior in Columbia-Suicide Severity Rating Scale (C-SSRS) within 1 year before start of screening phase.