Phase 3 N=615 Randomized Quadruple-blind Treatment

A Study of MD-120 in Patients With Depression

Major Depressive Disorder

Bottom Line

View on ClinicalTrials.gov: NCT04345471 ↗

Enrolled (actual)

615

Serious AEs

1.1%

Results posted

Feb 2024

Primary outcome: Primary: Changes in Total MADRS Score From the Baseline to Week 8 Visit During the Treatment Period — -10.4; -11.1; -11.9 Score on a scale — p=0.509

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Desvenlafaxine 100 mg (Drug); Desvenlafaxine 50 mg (Drug); Placebo (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Mochida Pharmaceutical Company, Ltd.
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in Total MADRS Score From the Baseline to Week 8 Visit During the Treatment Period	-10.4; -11.1; -11.9	0.509
PRIMARY Number of Participants With Adverse Events (AEs)	102; 117; 124	—
SECONDARY Changes in Total HAM-D17 Score From the Baseline to Week 8 Visit During the Treatment Period	-8.3; -8.4; -8.8	0.811
SECONDARY Number of Participants With Adverse Drug Reactions (ADRs)	—	—
SECONDARY Plasma Concentration of Desvenlafaxine	—	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04345471). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.