A Study of MD-120 in Patients With Depression | NCT04345471

ID	Type	Description	Link
JapicCTI-205252	Registry Identifier	JapicCTI

Name	Class
Pfizer	INDUSTRY

A Study of MD-120 in Patients With Depression | NCT04345471 | Trialant

Arms/Interventions Module

Label	Type	Intervention Names
MD-120 100 mg	Experimental	Drug: Desvenlafaxine 100 mg
MD-120 50 mg	Experimental	Drug: Desvenlafaxine 50 mg
Placebo	Placebo Comparator	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Desvenlafaxine 100 mg	Drug	once daily dosing for 8 weeks	MD-120 100 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in Total MADRS Score From the Baseline to Week 8 Visit During the Treatment Period	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.	8 weeks
Number of Participants With Adverse Events (AEs)	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.	10 weeks

Secondary Outcomes

Measure	Description	Time Frame
Changes in Total HAM-D17 Score From the Baseline to Week 8 Visit During the Treatment Period	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.

Contacts/Locations Module

Name	Affiliation	Role
Koichi Hayashi	Mochida Pharmaceutical Company, Ltd.	Study Director

Arm/Group Information

ID	Title	Description
FG000	Placebo	Placebo, orally, once daily for up to Week 8
FG001	MD-120 50 mg	MD-120 50 mg, orally, once daily for up to Week 8
FG002	MD-120 100 mg	MD-120 50 mg, orally, once daily for up to Week 1, followed by MD-120 100 mg, orally, once daily for up to Week 8

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000204 subjects FG001207 subjects FG002204 subjects
Received Treatment		FG000204 subjects FG001206 subjects FG002204 subjects
COMPLETED		FG000185 subjects FG001195 subjects FG002186 subjects
NOT COMPLETED		FG00019 subjects FG00112 subjects FG00218 subjects

Type	Comment	Reasons
Adverse Event		FG0008 subjects FG0015 subjects FG0026 subjects
Lack of Efficacy		FG000

Baseline Characteristics Module

ID	Title	Description
BG000	Placebo	Placebo, orally, once daily for up to Week 8
BG001	MD-120 50 mg	MD-120 50 mg, orally, once daily for up to Week 8

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

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.

Of subjects registered for randomization, those meeting all the following items were included in the full analysis set (FAS).

Subjects who received the investigational drug at least once during the treatment period.
Subjects who were evaluated for the total MADRS score at the baseline and at least one timepoint after the start of the treatment period.

Posted

Least Squares Mean

Standard Error

Score on a scale

8 weeks

ID	Title	Description
OG000	Placebo

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo, orally, once daily for up to Week 8	0

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
COVID-19	Infections and infestations	MedDRA version 25.0	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Director of Clinical Research Department	Mochida Pharmaceutical Company, Ltd.	+81332256331		clinical.trials.contact@mochida.co.jp

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 2, 2020	May 17, 2023	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Sep 14, 2022	May 17, 2023	SAP_001.pdf

Condition Browse Module

ID	Term
D003865	Depressive Disorder, Major

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Intervention Browse Module

ID	Term
D000069468	Desvenlafaxine Succinate

ID	Term
D003511	Cyclohexanols
D000441	Hexanols
D005233	Fatty Alcohols
D000438	Alcohols
D009930

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG0020 BG0030
Asian	BG000203 BG001206 BG002204 BG003613
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020 BG0030
Black or African American	BG0000 BG0010 BG0020 BG0030
White	BG0000 BG0010 BG0020 BG0030
More than one race	BG0000 BG0010 BG0020 BG0030
Unknown or Not Reported	BG0000 BG0010 BG0020 BG0030

Montgomery Asberg Depression Rating Scale (MADRS) Total Score

Mean

Standard Deviation

Scores on a scale

Title

Denominators

Categories

Title	Measurements
	BG00031.6± 4.9 BG00132.0± 4.7 BG00231.5± 4.7 BG00331.7± 4.8

Hamilton Depression Rating Scale-17 (HAM-D17) Total Score

Mean

Standard Deviation

Scores on a scale

Title

Denominators

Categories

Title	Measurements
	BG00024.3± 2.9 BG00124.3± 3.0 BG00223.8± 2.8 BG00324.1± 2.9

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		MMRM		0.509	A priori threshold for statistical significance is p<0.05, 2-sided.	LS mean difference	-0.6			2-Sided	95	-2.5	1.2					Superiority	To adjust for the multiplicity, only when the superiority of MD-120 50 mg to Placebo was verified, the superiority of MD-120 100 mg to Placebo was tested.
OG000 OG002		MMRM		0.131	A priori threshold for statistical significance is p<0.05, 2-sided. The value was based on the post-hoc analysis by not taking into account the multiplicity.	LS mean difference	-1.4			2-Sided	95	-3.3	0.4					Superiority	To adjust for the multiplicity, only when the superiority of MD-120 50 mg to Placebo was verified, the superiority of MD-120 100 mg to Placebo was tested.

Primary

Number of Participants With Adverse Events (AEs)

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.

Of subjects registered for randomization, those meeting all the following items will be included in the safety analysis set in treatment period.

Subjects who have received the investigational drug at least once during the treatment period.
Subjects in whom the safety evaluation data after the dose of the investigational drug in the treatment period are available.

Posted

Count of Participants

Participants

10 weeks

ID	Title	Description
OG000	Placebo	Placebo, orally, once daily for up to Week 8
OG001	MD-120 50 mg	MD-120 50 mg, orally, once daily for up to Week 8
OG002	MD-120 100 mg	MD-120 50 mg, orally, once daily for up to Week 1, followed by MD-120 100 mg, orally, once daily for up to Week 8

Units	Counts
Participants	OG000204 OG001206 OG002204

Title

Denominators

Categories

Title	Measurements
	OG000102 OG001117 OG002124

Secondary

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

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.

Of subjects registered for randomization, those meeting all the following items were included in the FAS.

Subjects who received the investigational drug at least once during the treatment period.
Subjects who were evaluated for the total MADRS score at the baseline and at least one timepoint after the start of the treatment period.

Posted

Least Squares Mean

Standard Error

Scores on a scale

8 weeks

ID	Title	Description
OG000	Placebo	Placebo, orally, once daily for up to Week 8
OG001	MD-120 50 mg	MD-120 50 mg, orally, once daily for up to Week 8
OG002	MD-120 100 mg	MD-120 50 mg, orally, once daily for up to Week 1, followed by MD-120 100 mg, orally, once daily for up to Week 8

Units	Counts
Participants	OG000203 OG001206 OG002204

Title

Denominators

Categories

Title	Measurements
	OG000-8.3± 0.5 OG001-8.4± 0.5 OG002-8.8± 0.5

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		MMRM		0.811	A priori threshold for statistical significance is p<0.05, 2-sided.	LS mean difference	-0.2			2-Sided	95	-1.5	1.2					Superiority
OG000 OG002		MMRM