Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
615 participants
INTERVENTIONAL
2020-05-18
2022-09-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MD-120 100 mg
Desvenlafaxine 100 mg
once daily dosing for 8 weeks
MD-120 50 mg
Desvenlafaxine 50 mg
once daily dosing for 8 weeks
Placebo
Placebo
once daily dosing for 8 weeks
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Hamilton Depression Rating Scale-17 (HAM-D17) total score of ≥20.
Exclusion Criteria
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.
20 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Mochida Pharmaceutical Company, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Koichi Hayashi
Role: STUDY_DIRECTOR
Mochida Pharmaceutical Company, Ltd.
Locations
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Mochida Investigational sites
Tokyo, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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JapicCTI-205252
Identifier Type: REGISTRY
Identifier Source: secondary_id
MD120101
Identifier Type: -
Identifier Source: org_study_id
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