Phase 3
Completed N=615
A Study of MD-120 in Patients With Depression
Source: ClinicalTrials.gov NCT04345471 ↗Enrolled (actual)
615
Serious AEs
1.1%
Results posted
Feb 2024
Primary outcomePrimary: 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
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
— | — |
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.
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. Informational only — not medical advice.