Trial · NCT04345471

A Study of MD-120 in Patients With Depression

NCT04345471, Phase 3, Completed, Mochida Pharmaceutical Company, Ltd.; results first posted 2024-02-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of MD-120 in Patients With Depression. Trials, record NCT04345471. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04345471

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of MD-120 in Patients With Depression
NCT number: NCT04345471
Status: Completed
Phases: Phase 3
Enrollment: 615 participants, actual
Lead sponsor: Mochida Pharmaceutical Company, Ltd.
Conditions: Major Depressive Disorder
Interventions: Desvenlafaxine 100 mg, Desvenlafaxine 50 mg, Placebo
First posted: 2020-04-14
Last updated: 2024-02-29
Results first posted: 2024-02-29

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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.
Primary	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	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.
Secondary	Number of Participants With Adverse Drug Reactions (ADRs)	10 weeks
Secondary	Plasma Concentration of Desvenlafaxine	Week 2 through week 8

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Changes in Total MADRS Score From the Baseline to Week 8 Visit During the Treatment Period	8 weeks	Of subjects registered for randomization, those meeting all the following items were included in the full analysis set (FAS).~1. Subjects who received the investigational drug at least once during the treatment period.~2. Subjects who were evaluated for the total MADRS score at the baseline and at least one timepoint after the start of the treatment period.	Score on a scale	LEAST_SQUARES_MEAN
PRIMARY	Number of Participants With Adverse Events (AEs)	10 weeks	Of subjects registered for randomization, those meeting all the following items will be included in the safety analysis set in treatment period.~1. Subjects who have received the investigational drug at least once during the treatment period.~2. Subjects in whom the safety evaluation data after the dose of the investigational drug in the treatment period are available.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Changes in Total HAM-D17 Score From the Baseline to Week 8 Visit During the Treatment Period	8 weeks	Of subjects registered for randomization, those meeting all the following items were included in the FAS.~1. Subjects who received the investigational drug at least once during the treatment period.~2. Subjects who were evaluated for the total MADRS score at the baseline and at least one timepoint after the start of the treatment period.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants With Adverse Drug Reactions (ADRs)	10 weeks
SECONDARY	Plasma Concentration of Desvenlafaxine	Week 2 through week 8

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Changes in Total MADRS Score From the Baseline to Week 8 Visit During the Treatment Period	Placebo	-10.4	Standard Error 0.7	Score on a scale
Changes in Total MADRS Score From the Baseline to Week 8 Visit During the Treatment Period	MD-120 50 mg	-11.1	Standard Error 0.7	Score on a scale
Changes in Total MADRS Score From the Baseline to Week 8 Visit During the Treatment Period	MD-120 100 mg	-11.9	Standard Error 0.7	Score on a scale
Number of Participants With Adverse Events (AEs)	Placebo	102		Participants
Number of Participants With Adverse Events (AEs)	MD-120 50 mg	117		Participants
Number of Participants With Adverse Events (AEs)	MD-120 100 mg	124		Participants
Changes in Total HAM-D17 Score From the Baseline to Week 8 Visit During the Treatment Period	Placebo	-8.3	Standard Error 0.5	Scores on a scale
Changes in Total HAM-D17 Score From the Baseline to Week 8 Visit During the Treatment Period	MD-120 50 mg	-8.4	Standard Error 0.5	Scores on a scale
Changes in Total HAM-D17 Score From the Baseline to Week 8 Visit During the Treatment Period	MD-120 100 mg	-8.8	Standard Error 0.5	Scores on a scale

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	204
Overall Study	STARTED	MD-120 50 mg	207
Overall Study	STARTED	MD-120 100 mg	204
Overall Study	Received Treatment	Placebo	204
Overall Study	Received Treatment	MD-120 50 mg	206
Overall Study	Received Treatment	MD-120 100 mg	204
Overall Study	COMPLETED	Placebo	185
Overall Study	COMPLETED	MD-120 50 mg	195
Overall Study	COMPLETED	MD-120 100 mg	186
Overall Study	NOT COMPLETED	Placebo	19

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events39

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	Gastrointestinal disorders	Placebo	14	204
other	Nausea	Gastrointestinal disorders	MD-120 50 mg	27	206
other	Nausea	Gastrointestinal disorders	MD-120 100 mg	35	204
other	Somnolence	Nervous system disorders	Placebo	7	204
other	Somnolence	Nervous system disorders	MD-120 50 mg	13	206
other	Somnolence	Nervous system disorders	MD-120 100 mg	18	204
other	Dizziness	Nervous system disorders	Placebo	2	204
other	Dizziness	Nervous system disorders	MD-120 50 mg	16	206
other	Dizziness	Nervous system disorders	MD-120 100 mg	15	204
other	Weight decreased	Investigations	Placebo	1	204

1 to 10 of 39Source ClinicalTrials.gov

See all 39 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	204
Total, all-cause mortality	MD-120 50 mg	0	206
Total, all-cause mortality	MD-120 100 mg	0	204
Total, other adverse events	Placebo	43	204
Total, other adverse events	MD-120 50 mg	67	206
Total, other adverse events	MD-120 100 mg	71	204
Total, serious adverse events	Placebo	2	204
Total, serious adverse events	MD-120 50 mg	3	206
Total, serious adverse events	MD-120 100 mg	2	204

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04345471

GET https://conductscience.org/api/trials/v1/NCT04345471/events?page=2

API reference For AI assistants