Trial Outcomes & Findings for A Study of MD-120 in Patients With Depression (NCT NCT04345471)

Last Updated: 2024-02-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

615 participants

Primary outcome timeframe

8 weeks

Results posted on

2024-02-29

Participant Flow

Participants took part in the study at 82 investigational sites in Japan from 18 May 2020 to 14 September 2022.

Participants who met entry criteria were enrolled placebo lead-in period for one week prior to randomization, after that participants randomized and enrolled in one of three treatment group (Placebo group, MD-120 50 mg group, MD-120 100 mg group) for 8 weeks as double-blind treatment period.

Participant milestones

Participant milestones
Measure	Placebo Placebo, orally, once daily for up to Week 8	MD-120 50 mg MD-120 50 mg, orally, once daily for up to Week 8	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
Overall Study STARTED	204	207	204
Overall Study Received Treatment	204	206	204
Overall Study COMPLETED	185	195	186
Overall Study NOT COMPLETED	19	12	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo, orally, once daily for up to Week 8	MD-120 50 mg MD-120 50 mg, orally, once daily for up to Week 8	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
Overall Study Adverse Event	8	5	6
Overall Study Lack of Efficacy	1	1	0
Overall Study Protocol Violation	0	1	2
Overall Study Withdrawal by Subject	10	5	10

Baseline Characteristics

A Study of MD-120 in Patients With Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=203 Participants Placebo, orally, once daily for up to Week 8	MD-120 50 mg n=206 Participants MD-120 50 mg, orally, once daily for up to Week 8	MD-120 100 mg n=204 Participants 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	Total n=613 Participants Total of all reporting groups
Age, Continuous	40.2 Years STANDARD_DEVIATION 12.0 • n=5 Participants	39.8 Years STANDARD_DEVIATION 12.1 • n=7 Participants	39.6 Years STANDARD_DEVIATION 12.7 • n=5 Participants	39.8 Years STANDARD_DEVIATION 12.2 • n=4 Participants
Sex: Female, Male Female	102 Participants n=5 Participants	104 Participants n=7 Participants	91 Participants n=5 Participants	297 Participants n=4 Participants
Sex: Female, Male Male	101 Participants n=5 Participants	102 Participants n=7 Participants	113 Participants n=5 Participants	316 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	203 Participants n=5 Participants	206 Participants n=7 Participants	204 Participants n=5 Participants	613 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Japan	203 participants n=5 Participants	206 participants n=7 Participants	204 participants n=5 Participants	613 participants n=4 Participants
Montgomery Asberg Depression Rating Scale (MADRS) Total Score	31.6 Scores on a scale STANDARD_DEVIATION 4.9 • n=5 Participants	32.0 Scores on a scale STANDARD_DEVIATION 4.7 • n=7 Participants	31.5 Scores on a scale STANDARD_DEVIATION 4.7 • n=5 Participants	31.7 Scores on a scale STANDARD_DEVIATION 4.8 • n=4 Participants
Hamilton Depression Rating Scale-17 (HAM-D17) Total Score	24.3 Scores on a scale STANDARD_DEVIATION 2.9 • n=5 Participants	24.3 Scores on a scale STANDARD_DEVIATION 3.0 • n=7 Participants	23.8 Scores on a scale STANDARD_DEVIATION 2.8 • n=5 Participants	24.1 Scores on a scale STANDARD_DEVIATION 2.9 • n=4 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=203 Participants Placebo, orally, once daily for up to Week 8	MD-120 50 mg n=206 Participants MD-120 50 mg, orally, once daily for up to Week 8	MD-120 100 mg n=204 Participants 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
Changes in Total MADRS Score From the Baseline to Week 8 Visit During the Treatment Period	-10.4 Score on a scale Standard Error 0.7	-11.1 Score on a scale Standard Error 0.7	-11.9 Score on a scale Standard Error 0.7

PRIMARY outcome

Timeframe: 10 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=204 Participants Placebo, orally, once daily for up to Week 8	MD-120 50 mg n=206 Participants MD-120 50 mg, orally, once daily for up to Week 8	MD-120 100 mg n=204 Participants 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
Number of Participants With Adverse Events (AEs)	102 Participants	117 Participants	124 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=203 Participants Placebo, orally, once daily for up to Week 8	MD-120 50 mg n=206 Participants MD-120 50 mg, orally, once daily for up to Week 8	MD-120 100 mg n=204 Participants 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
Changes in Total HAM-D17 Score From the Baseline to Week 8 Visit During the Treatment Period	-8.3 Scores on a scale Standard Error 0.5	-8.4 Scores on a scale Standard Error 0.5	-8.8 Scores on a scale Standard Error 0.5

SECONDARY outcome

Timeframe: 10 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 2 through week 8

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 43 other events

Deaths: 0 deaths

MD-120 50 mg

Serious events: 3 serious events

Other events: 67 other events

Deaths: 0 deaths

MD-120 100 mg

Serious events: 2 serious events

Other events: 71 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=204 participants at risk Placebo, orally, once daily for up to Week 8	MD-120 50 mg n=206 participants at risk MD-120 50 mg, orally, once daily for up to Week 8	MD-120 100 mg n=204 participants at risk 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
Infections and infestations COVID-19	0.49% 1/204 • 10 weeks	0.00% 0/206 • 10 weeks	0.49% 1/204 • 10 weeks
Infections and infestations Pneumonia	0.00% 0/204 • 10 weeks	0.49% 1/206 • 10 weeks	0.00% 0/204 • 10 weeks
Infections and infestations Tonsillitis	0.49% 1/204 • 10 weeks	0.00% 0/206 • 10 weeks	0.00% 0/204 • 10 weeks
Cardiac disorders Acute myocardial infarction	0.00% 0/204 • 10 weeks	0.49% 1/206 • 10 weeks	0.00% 0/204 • 10 weeks
Vascular disorders Aortic dissection	0.00% 0/204 • 10 weeks	0.49% 1/206 • 10 weeks	0.00% 0/204 • 10 weeks
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/204 • 10 weeks	0.00% 0/206 • 10 weeks	0.49% 1/204 • 10 weeks

Other adverse events

Other adverse events
Measure	Placebo n=204 participants at risk Placebo, orally, once daily for up to Week 8	MD-120 50 mg n=206 participants at risk MD-120 50 mg, orally, once daily for up to Week 8	MD-120 100 mg n=204 participants at risk 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
Gastrointestinal disorders Nausea	6.9% 14/204 • 10 weeks	13.1% 27/206 • 10 weeks	17.2% 35/204 • 10 weeks
Nervous system disorders Somnolence	3.4% 7/204 • 10 weeks	6.3% 13/206 • 10 weeks	8.8% 18/204 • 10 weeks
Nervous system disorders Dizziness	0.98% 2/204 • 10 weeks	7.8% 16/206 • 10 weeks	7.4% 15/204 • 10 weeks
Investigations Weight decreased	0.49% 1/204 • 10 weeks	2.4% 5/206 • 10 weeks	5.9% 12/204 • 10 weeks
General disorders Pyrexia	5.4% 11/204 • 10 weeks	4.9% 10/206 • 10 weeks	3.9% 8/204 • 10 weeks
Infections and infestations Nasopharyngitis	6.4% 13/204 • 10 weeks	4.4% 9/206 • 10 weeks	3.9% 8/204 • 10 weeks
Nervous system disorders Headache	1.5% 3/204 • 10 weeks	7.3% 15/206 • 10 weeks	3.4% 7/204 • 10 weeks

Additional Information

Director of Clinical Research Department

Mochida Pharmaceutical Company, Ltd.

Phone: +81332256331

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI shall not publish the Study results at any time without the prior written approval of the Sponsor.
Publication restrictions are in place

Restriction type: OTHER