A Study of MD-120 in Patients With Depression

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Desvenlafaxine 100 mg; Drug: Desvenlafaxine 50 mg; Drug: Placebo

• Registration Number: NCT04345471
• Lead Sponsor: Mochida Pharmaceutical Company, Ltd.

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 available

Study Timeline

• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-04-10
• Study First Posted: 2020-04-14
• Study Start: 2020-05-18
• Primary Completion: 2022-07-21
• Study Completion: 2022-09-14
• Results First Submitted: 2023-05-23
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-27
• Last Update Submitted: 2024-02-27
• Results First Posted: 2024-02-29
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 615

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MD-120 100 mg	Desvenlafaxine 100 mg	-
MD-120 50 mg	Desvenlafaxine 50 mg	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Changes in Total MADRS Score From the Baseline to Week 8 Visit During the Treatment Period	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.
Number of Participants With Adverse Events (AEs)	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 Outcome Measures

Name	Time	Method
Plasma Concentration of Desvenlafaxine	Week 2 through week 8
Changes in Total HAM-D17 Score From the Baseline to Week 8 Visit During the Treatment Period	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.
Number of Participants With Adverse Drug Reactions (ADRs)	10 weeks

Trial Locations

Locations (1)

Mochida Investigational sites; 🇯🇵 Tokyo, Japan