Back to resultsA Study of MD-120 in Patients With Depression
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Desvenlafaxine 100 mg
Desvenlafaxine 50 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
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).
- 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.
Sites / Locations
- Mochida Investigational sites
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
MD-120 100 mg
MD-120 50 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score: Scale ranges from 0 to 60 with a higher score indicating worsening symptoms of depression.
Number of Participants With Adverse Events (AEs)
Secondary Outcome Measures
Change from Baseline in Hamilton Depression Rating Scale-17 (HAM-D17) Total Score
Hamilton Depression Rating Scale-17 (HAM-D17) Total Score: Scale ranges from 0 to 52 with a higher score indicating worsening symptoms of depression.
Number of Participants With Adverse Drug Reactions (ADRs)
Plasma Concentration of desvenlafaxine
Full Information
NCT ID
NCT04345471
First Posted
April 6, 2020
Last Updated
September 28, 2022
Sponsor
Mochida Pharmaceutical Company, Ltd.
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT04345471
Brief Title
A Study of MD-120 in Patients With Depression
Official Title
A Placebo-controlled Study of MD-120 in Patients With Depression
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 18, 2020 (Actual)
Primary Completion Date
July 21, 2022 (Actual)
Study Completion Date
September 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mochida Pharmaceutical Company, Ltd.
Collaborators
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
615 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MD-120 100 mg
Arm Type
Experimental
Arm Title
MD-120 50 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Desvenlafaxine 100 mg
Intervention Description
once daily dosing for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Desvenlafaxine 50 mg
Intervention Description
once daily dosing for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
once daily dosing for 8 weeks
Primary Outcome Measure Information:
Title
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Description
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score: Scale ranges from 0 to 60 with a higher score indicating worsening symptoms of depression.
Time Frame
8 weeks
Title
Number of Participants With Adverse Events (AEs)
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Hamilton Depression Rating Scale-17 (HAM-D17) Total Score
Description
Hamilton Depression Rating Scale-17 (HAM-D17) Total Score: Scale ranges from 0 to 52 with a higher score indicating worsening symptoms of depression.
Time Frame
8 weeks
Title
Number of Participants With Adverse Drug Reactions (ADRs)
Time Frame
10 weeks
Title
Plasma Concentration of desvenlafaxine
Time Frame
Week 2 through week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koichi Hayashi
Organizational Affiliation
Mochida Pharmaceutical Company, Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Mochida Investigational sites
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of MD-120 in Patients With Depression
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