A Phase 3 interventional study of Desvenlafaxine 100 mg and Desvenlafaxine 50 mg in Major Depressive Disorder, sponsored by Mochida Pharmaceutical Company, Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-02-29.
Sponsored by Mochida Pharmaceutical Company, Ltd. · Phase 3, Interventional, and Treatment
Among 28 studies testing desvenlafaxine in Depressive Disorder, Major — none open to participants now, 1 under way, none of them phase 3. desvenlafaxine · Depressive Disorder, Major.
Among the 28 studies testing desvenlafaxine in Depressive Disorder, Major, this one is the 6th largest by enrollment of the 27 interventional ones that give a count, is the only one that started in 2020, is one of 19 in phase 3, and was the 27th registered.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
Browse Depressive Disorder, Major studies →None of the 28 studies testing desvenlafaxine in Depressive Disorder, Major is open now. The open studies under Depressive Disorder, Major, anywhere →
desvenlafaxine: first FDA approval 2008 (PRISTIQ). What it is approved for, and how studies give it, is on its page →
Of the 410 Depressive Disorder, Major studies recruiting now, 92 (22%) set no upper age limit and 292 (71%) stop at 75 or younger; 54 take children under 18; 98 take healthy volunteers.
This study: 20 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
28 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 615 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Median enrollment 369 across the 27 interventional studies. Of the 24 that completed or were terminated, 9 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
22 of 28 have an industry lead sponsor. The 9 most frequent:
Mochida Pharmaceutical Company, Ltd. is the lead sponsor of 12 studies on the registry; none are open to participants now.
Mochida Pharmaceutical Company, Ltd. has 1 study filed under Depressive Disorder, Major — fewer than ten, so there is no comparison to draw.
1 of the studies testing desvenlafaxine in Depressive Disorder, Major that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05273996David SteffensPredictors of Cognitive Outcomes in Geriatric Depression | 2027-04-30 |
Add it to your calendar (.ics) → With an account.
Among the 28 studies testing desvenlafaxine in Depressive Disorder, Major, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Schizophrenia spectrum and other psychotic disorders Bipolar and related disorders Substance use disorders (exclusive of tobacco and caffeine)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Desvenlafaxine 100 mg
Drug: Desvenlafaxine 50 mg
Drug: Placebo
once daily dosing for 8 weeks
once daily dosing for 8 weeks
once daily dosing for 8 weeks
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.
Time frame: 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.
Time frame: 10 weeks
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.
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
Participants took part in the study at 82 investigational sites in Japan from 18 May 2020 to 14 September 2022.
| Milestone | Placebo | MD-120 50 mg | MD-120 100 mg |
|---|---|---|---|
| Started | 204 | 207 | 204 |
| Received treatment | 204 | 206 | 204 |
| Completed | 185 | 195 | 186 |
| Not completed | 19 | 12 | 18 |
| Withdrew: Adverse event | 8 | 5 | 6 |
| Withdrew: Lack of efficacy | 1 | 1 | 0 |
| Withdrew: Protocol violation | 0 | 1 | 2 |
| Withdrew: Withdrawal by subject | 10 | 5 | 10 |
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.
| Score on a scale | Placebo | MD-120 50 mg | MD-120 100 mg |
|---|---|---|---|
| Changes in Total MADRS Score From the Baseline to Week 8 Visit During the Treatment Period | -10.4 ± 0.7 | -11.1 ± 0.7 | -11.9 ± 0.7 |
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.
| Participants | Placebo | MD-120 50 mg | MD-120 100 mg |
|---|---|---|---|
| Number of Participants With Adverse Events (AEs) | 102 | 117 | 124 |
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.
| Scores on a scale | Placebo | MD-120 50 mg | MD-120 100 mg |
|---|---|---|---|
| Changes in Total HAM-D17 Score From the Baseline to Week 8 Visit During the Treatment Period | -8.3 ± 0.5 | -8.4 ± 0.5 | -8.8 ± 0.5 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over 10 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/204 (0%) | 2/204 (1%) | 43/204 (21.1%) |
| MD-120 50 mg | 0/206 (0%) | 3/206 (1.5%) | 67/206 (32.5%) |
| MD-120 100 mg | 0/204 (0%) | 2/204 (1%) | 71/204 (34.8%) |
| Event | Placebo | MD-120 50 mg | MD-120 100 mg |
|---|---|---|---|
| COVID-19Infections and infestations | 1/204 | 0/206 | 1/204 |
| TonsillitisInfections and infestations | 1/204 | 0/206 | 0/204 |
| Clavicle fractureInjury, poisoning and procedural complications | 0/204 | 0/206 | 1/204 |
| PneumoniaInfections and infestations | 0/204 | 1/206 | 0/204 |
| Acute myocardial infarctionCardiac disorders | 0/204 | 1/206 | 0/204 |
| Aortic dissectionVascular disorders | 0/204 | 1/206 | 0/204 |
| Event | Placebo | MD-120 50 mg | MD-120 100 mg |
|---|---|---|---|
| NauseaGastrointestinal disorders | 14/204 | 27/206 | 35/204 |
| SomnolenceNervous system disorders | 7/204 | 13/206 | 18/204 |
| DizzinessNervous system disorders | 2/204 | 16/206 | 15/204 |
| HeadacheNervous system disorders | 3/204 | 15/206 | 7/204 |
| NasopharyngitisInfections and infestations | 13/204 | 9/206 | 8/204 |
| Weight decreasedInvestigations | 1/204 | 5/206 | 12/204 |
| PyrexiaGeneral disorders | 11/204 | 10/206 | 8/204 |
| Age, Continuous(Years) | Placebo | MD-120 50 mg | MD-120 100 mg | Total |
|---|---|---|---|---|
| Mean | 40.2 ± 12.0 | 39.8 ± 12.1 | 39.6 ± 12.7 | 39.8 ± 12.2 |
| Sex: Female, Male(Participants) | Placebo | MD-120 50 mg | MD-120 100 mg | Total |
|---|---|---|---|---|
| Female | 102 | 104 | 91 | 297 |
| Male | 101 | 102 | 113 | 316 |
| Race (NIH/OMB)(Participants) | Placebo | MD-120 50 mg | MD-120 100 mg | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 203 | 206 | 204 | 613 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Placebo | MD-120 50 mg | MD-120 100 mg | Total |
|---|---|---|---|---|
| Japan | 203 | 206 | 204 | 613 |
| Montgomery Asberg Depression Rating Scale (MADRS) Total Score(Scores on a scale) | Placebo | MD-120 50 mg | MD-120 100 mg | Total |
|---|---|---|---|---|
| Mean | 31.6 ± 4.9 | 32.0 ± 4.7 | 31.5 ± 4.7 | 31.7 ± 4.8 |
| Hamilton Depression Rating Scale-17 (HAM-D17) Total Score(Scores on a scale) | Placebo | MD-120 50 mg | MD-120 100 mg | Total |
|---|---|---|---|---|
| Mean | 24.3 ± 2.9 | 24.3 ± 3.0 | 23.8 ± 2.8 | 24.1 ± 2.9 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2020 to primary completion in Jul 2022, 26 months.
Results were first posted in Feb 2024, 1 year 7 months after primary completion.
Of 95 industry-sponsored phase 3 interventional studies under Depressive Disorder, Major, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 33. This study's 26 months is close to that.
Counting every sponsor, half of 124 studies reached it within 27 months; a quarter within 21 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Desvenlafaxine
Mochida Pharmaceutical Company, Ltd.