NCT04345471

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
615

participants targeted

Target at P75+ for phase_3 major-depressive-disorder

Timeline
Completed

Started May 2020

Typical duration for phase_3 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

May 18, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 29, 2024

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

2.2 years

First QC Date

April 6, 2020

Results QC Date

May 23, 2023

Last Update Submit

February 27, 2024

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Changes in Total HAM-D17 Score From the Baseline to Week 8 Visit During the Treatment Period

    8 weeks

  • Number of Participants With Adverse Drug Reactions (ADRs)

    10 weeks

  • Plasma Concentration of Desvenlafaxine

    Week 2 through week 8

Study Arms (3)

MD-120 100 mg

EXPERIMENTAL
Drug: Desvenlafaxine 100 mg

MD-120 50 mg

EXPERIMENTAL
Drug: Desvenlafaxine 50 mg

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Desvenlafaxine 100 mgDRUG

once daily dosing for 8 weeks

MD-120 100 mg
Desvenlafaxine 50 mgDRUG

once daily dosing for 8 weeks

MD-120 50 mg
PlaceboDRUG

once daily dosing for 8 weeks

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mochida Investigational sites

Tokyo, Japan

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Desvenlafaxine Succinate

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticLipids

Results Point of Contact

Title
Director of Clinical Research Department
Organization
Mochida Pharmaceutical Company, Ltd.
clinical.trials.contact@mochida.co.jp
+81332256331

Study Officials

  • Koichi Hayashi

    Mochida Pharmaceutical Company, Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2020

First Posted

April 14, 2020

Study Start

May 18, 2020

Primary Completion

July 21, 2022

Study Completion

September 14, 2022

Last Updated

February 29, 2024

Results First Posted

February 29, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)