A Study of MD-120 in Patients With Depression

NCT04345471

Last updated date
Study Location
Mochida Investigational sites
Tokyo, , , Japan
Contact
+81-3-3225-6332

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of MD-120 in Patients With Depression
Official Title  ICMJE A Placebo-controlled Study of MD-120 in Patients With Depression
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Desvenlafaxine 100 mg
    once daily dosing for 8 weeks
  • Drug: Desvenlafaxine 50 mg
    once daily dosing for 8 weeks
  • Drug: Placebo
    once daily dosing for 8 weeks
Study Arms  ICMJE
  • Experimental: MD-120 100 mg
    Intervention: Drug: Desvenlafaxine 100 mg
  • Experimental: MD-120 50 mg
    Intervention: Drug: Desvenlafaxine 50 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2020)
594
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mochida Clinical Research Department+81-3-3225-6332[email protected]
Contact: Mochida Public Relations Office[email protected]
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04345471
Other Study ID Numbers  ICMJE MD120101
JapicCTI-205252 ( Registry Identifier: JapicCTI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Mochida Pharmaceutical Company, Ltd.
Study Sponsor  ICMJE Mochida Pharmaceutical Company, Ltd.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Koichi HayashiMochida Pharmaceutical Company, Ltd.
PRS Account Mochida Pharmaceutical Company, Ltd.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP