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Completed

NCT Number: NCT04345471

A Study of MD-120 in Patients With Depression

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mochida Investigational sites

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

desvenlafaxine 100 mg

Drug

once daily dosing for 8 weeks

desvenlafaxine 50 mg

Drug

once daily dosing for 8 weeks

Placebo

Drug

once daily dosing for 8 weeks

Primary outcomes

  1. Changes in Total MADRS Score From the Baseline to Week 8 Visit During the Treatment Period

    Time frame: 8 weeks

    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.

  2. Number of Participants With Adverse Events (AEs)

    Time frame: 10 weeks

    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.

Secondary outcomes

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

    Time frame: 8 weeks

    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.

  2. Number of Participants With Adverse Drug Reactions (ADRs)

    Time frame: 10 weeks

  3. Plasma Concentration of Desvenlafaxine

    Time frame: Week 2 through week 8

Sponsors and collaborators

Lead sponsor

Mochida Pharmaceutical Company, Ltd.

Industry

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2020
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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