A Study of MD-120 in Patients With Depression

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04345471
• Other study ID #: MD120101
• Secondary ID: JapicCTI-205252
• Status: Completed
• Phase: Phase 3
• Start date: May 18, 2020
• Est. completion date: September 14, 2022

Study information

• Verified date: February 2024
• Source: Mochida Pharmaceutical Company, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 615
• Est. completion date: September 14, 2022
• Est. primary completion date: July 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Desvenlafaxine 100 mg
once daily dosing for 8 weeks
• Desvenlafaxine 50 mg
once daily dosing for 8 weeks
• Placebo
once daily dosing for 8 weeks

Locations

Country	Name	City	State
Japan	Mochida Investigational sites	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Mochida Pharmaceutical Company, Ltd.	Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Total MADRS Score From the Baseline to Week 8 Visit During the Treatment Period	Montgomery-Asberg Depression Rating Scale (MADRS) Total Score: Scale ranges from 0 to 60 with a higher score indicating worsening symptoms of depression. Estimates were based on a Mixed-effects Model for Repeated Measures (MMRM) model with the treatment group, assessment timepoint, and the interaction between the treatment group and assessment timepoint as a factor and total MADRS score at baseline as a covariate.	8 weeks
Primary	Number of Participants With Adverse Events (AEs)	An adverse event is any undesirable or unintended sign (including abnormal findings in general laboratory tests, body weight, and standard 12-lead ECG), symptom, or disease in a subject given the investigational drug, irrespective of the causal relationship to the investigational drug.	10 weeks
Secondary	Changes in Total HAM-D17 Score From the Baseline to Week 8 Visit During the Treatment Period	Hamilton Depression Rating Scale-17 (HAM-D17) Total Score: Scale ranges from 0 to 52 with a higher score indicating worsening symptoms of depression. Estimates were based on a MMRM model with the treatment group, assessment timepoint, and the interaction between the treatment group and assessment timepoint as a factor and total HAM-D17 score at baseline as a covariate.	8 weeks
Secondary	Number of Participants With Adverse Drug Reactions (ADRs)		10 weeks
Secondary	Plasma Concentration of Desvenlafaxine		Week 2 through week 8