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A Study of MD-120 in Patients With Depression

CompletedPhase 3

Sponsor: Mochida Pharmaceutical Company, Ltd.

Conditions: Major Depressive Disorder

Interventions: Desvenlafaxine 100 mg, Desvenlafaxine 50 mg, Placebo

Countries: Japan

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.

Eligibility overview

Sex: ALL

Age: 20 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Tokyo, Japan