Status:
COMPLETED
A Study of MD-120 in Patients With Depression
Lead Sponsor:
Mochida Pharmaceutical Company, Ltd.
Collaborating Sponsors:
Pfizer
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2022
Estimated Enrollment :
615 Patients enrolled
Trial Details
Trial ID
NCT04345471
Start Date
May 18 2020
End Date
September 14 2022
Last Update
February 29 2024
Active Locations (1)
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1
Mochida Investigational sites
Tokyo, Japan