A Study of MD-120 in Patients With Depression

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mochida Pharmaceutical Company, Ltd.
• Collaborator: Pfizer
• Treatments: Desvenlafaxine Succinate

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).

• HAM-D 17 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.