Major Depressive DisorderPhase 3NCT04345471

A Study of MD-120 in Patients With Depression

A Phase 3 study testing Desvenlafaxine 100 mg and Desvenlafaxine 50 mg in people with Major Depressive Disorder, run by Mochida Pharmaceutical Company, Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Major Depressive Disorder
What is being tested?: Desvenlafaxine 100 mg and Desvenlafaxine 50 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 615 participants
Where: 1 siteJapan
Study dates: 18 May 2020to 14 Sep 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Mochida Investigational sites
Tokyo

Other trials in Japan

About this study

Official title: A Placebo-controlled Study of MD-120 in Patients With Depression

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.

Conditions: Major Depressive Disorder
Being tested: Desvenlafaxine 100 mg, Desvenlafaxine 50 mg, Placebo
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Desvenlafaxine 100 mgDrug
once daily dosing for 8 weeks
Desvenlafaxine 50 mgDrug
once daily dosing for 8 weeks
PlaceboDrug
once daily dosing for 8 weeks

Study groups in NCT04345471
Study group	Role	What they receive
MD-120 100 mg	Experimental	Not described Receives: Drug: Desvenlafaxine 100 mg
MD-120 50 mg	Experimental	Not described Receives: Drug: Desvenlafaxine 50 mg
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 10 weeks

Secondary outcomes (3)

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.
Measured: 8 weeks
Number of Participants With Adverse Drug Reactions (ADRs)
Measured: 10 weeks
Plasma Concentration of Desvenlafaxine
Measured: Week 2 through week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 May 202014 Sep 2022

First posted14 Apr 2020
Study start18 May 2020
Primary completion21 Jul 2022
Study completion14 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 615 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04345471
Sponsor's protocol ID: MD120101
Other IDs: JapicCTI-205252
Status last verified: Feb 2024
First submitted: 6 Apr 2020
Last updated: 29 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Placebo-controlled Study of MD-120 in Patients With Depression
ClinicalTrials.gov ID: NCT04345471
Acronym / sponsor ID: MD120101
Conditions: Major Depressive Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 615 participants (actual)
Lead sponsor: Mochida Pharmaceutical Company, Ltd.Industry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: 18 May 2020 (actual)
Primary completion: 21 Jul 2022 (actual)
Study completion: 14 Sep 2022 (actual)
First posted: 14 Apr 2020 (actual)
Results: Posted 29 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
MD-120 100 mg	Experimental	Drug: Desvenlafaxine 100 mg
MD-120 50 mg	Experimental	Drug: Desvenlafaxine 50 mg
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Desvenlafaxine 100 mgonce daily dosing for 8 weeks	Drug	MD-120 100 mg
Desvenlafaxine 50 mgonce daily dosing for 8 weeks	Drug	MD-120 50 mg
Placeboonce daily dosing for 8 weeks	Drug	Placebo

Primary outcome

Changes in Total MADRS Score From the Baseline to Week 8 Visit During the Treatment Period
Time frame: 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.
Number of Participants With Adverse Events (AEs)
Time frame: 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.

3 secondary outcomes

Changes in Total HAM-D17 Score From the Baseline to Week 8 Visit During the Treatment Period
Time frame: 8 weeks
Number of Participants With Adverse Drug Reactions (ADRs)
Time frame: 10 weeks
Plasma Concentration of Desvenlafaxine
Time frame: Week 2 through week 8

Results and safety

Results posted to the registry on 29 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	204	185
MD-120 50 mg	207	195
MD-120 100 mg	204	186

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

Time frame: 8 weeks. Least squares mean (Standard Error). Unit: Score on a scale

Measure	Placebo n = 203	MD-120 50 mg n = 206	MD-120 100 mg n = 204
Value	-10.4 (0.7)	-11.1 (0.7)	-11.9 (0.7)

Placebo vs MD-120 50 mg: LS mean difference: -0.6 (95% CI -2.5 to 1.2), p = 0.509, MMRM
Placebo vs MD-120 100 mg: LS mean difference: -1.4 (95% CI -3.3 to 0.4), p = 0.131, MMRM

Population analysed: 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.

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: 10 weeks. Count of participants. Unit: Participants

Measure	Placebo n = 204	MD-120 50 mg n = 206	MD-120 100 mg n = 204
Value	102	117	124

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 10 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of 204 (1%)	43 of 204 (21.1%)	0 of 204
MD-120 50 mg	3 of 206 (1.5%)	67 of 206 (32.5%)	0 of 206
MD-120 100 mg	2 of 204 (1%)	71 of 204 (34.8%)	0 of 204

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Major Depressive Disorder

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Koichi Hayashi study director

Mochida Pharmaceutical Company, Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Desvenlafaxine 100 mg and Desvenlafaxine 50 mg in people with Major Depressive Disorder, run by Mochida Pharmaceutical Company, Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Total MADRS Score From the Baseline to Week 8 Visit During the Treatment Period (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04345471.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.