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

A Study of MD-120 in Patients With Depression

615

The proportion of female subjects in the FAS was 50.2%, 50.5% and 44.6% in the placebo, MD-120 50 mg and MD-120 100 mg groups, respectively. The age (mean(SD)) was 40.2(12.0), 39.8(12.1) and 39.6(12.7) years, respectively. The baseline total MADRS score (mean(SD)) was 31.6(4.9), 32.0(4.7) and 31.5(4.7), respectively. The baseline total HAMD17 score (mean(SD)) was 24.3(2.9), 24.3(3.0) and 23.8(2.8), respectively.

615 subjects (204 subjects in the placebo group, 207 subjects in the MD-120 50 mg group, and 204 subjects in the MD-120 100 mg group) were registered for randomization. Of subjects registered for randomization, 614 subjects excluding 1 subject in the MD-120 50 mg group received the investigational drug during the treatment period. The number of subjects who discontinued the clinical study during the treatment period was 49 (19 subjects in the placebo group, 12 subjects in the MD-120 50 mg group, and 18 subjects in the MD-120 100 mg group). The main reasons for discontinuation were "Adverse events" (8 subjects in the placebo group, 5 subjects in the MD-120 50 mg group, and 6 subjects in the MD-120 100 mg group) and "Convenience of the subject" (10 subjects in the placebo group, 5 subjects in the MD-120 50 mg group, and 10 subjects in the MD-120 100 mg group).

No adverse events in subjects who died occurred. The incidences of serious adverse events observed during the treatment and follow-up periods were 1.0% (2/204 subjects), 1.5% (3/206 subjects), and 1.0% (2/204 subjects) in the placebo, MD-120 50 mg, and MD-120 100 mg groups, respectively. Serious adverse events were tonsillitis and COVID-19 (1 subject each) in the placebo group, pneumonia, acute myocardial infarction, and aortic dissection (1 subject each) in the MD-120 50 mg group, and COVID-19 and clavicle fracture (1 subject each) in the MD-120 100 mg group. These causal relationships with the investigational drug were ruled out. Adverse events with an incidence of >=5% in any of the treatment groups during the treatment and follow-up periods were nausea, somnolence, dizziness, weight decreased, pyrexia, nasopharyngitis and headache.

The change in total MADRS score from baseline to Week 8 visit during the treatment period (adjusted mean) in the FAS, the primary endpoint, was -10.4, -11.1, and -11.9 in the placebo, MD-120 50 mg, and MD-120 100 mg groups, respectively. The adjusted mean difference from the placebo group (two-sided 95% confidence interval) was -0.6 (-2.5 to 1.2) for the MD-120 50 mg group, demonstrating no superiority of the MD-120 50 mg group to the placebo group (MMRM analysis, p=0.509). Because the superiority of the MD-120 50 mg group to the placebo group was not demonstrated, the superiority of the MD-120 100 mg group to the placebo group was not verified according to the closed testing procedure planned in advance. The adjusted mean difference from the placebo group (two-sided 95% confidence interval) was -1.4 (-3.3 to 0.4) for the MD-120 100 mg group in a post-hoc analysis by not taking into account the multiplicity, demonstrating no statistically significant difference from the placebo group for the MD-120 100 mg group (MMRM analysis, p=0.131).

The change in total HAMD17 score from baseline to Week 8 visit during the treatment period (adjusted mean) in the FAS, the secondary endpoint, was -8.3, -8.4, and -8.8 in the placebo, MD-120 50 mg, and MD-120 100 mg groups, respectively. The adjusted mean differences from the placebo group (two-sided 95% confidence interval) were -0.2 (-1.5 to 1.2) and -0.5 (-1.9 to 0.8) for the MD-120 50 mg and MD-120 100 mg groups, respectively, showing no statistically significant differences from the placebo group for the MD-120 50 mg and MD-120 100 mg groups (MMRM analysis, p=0.811 and p=0.424).

For the primary efficacy endpoint, superiority of the MD-120 50 mg group to the placebo group was not demonstrated. In accordance with the predetermined closed testing procedure, the superiority of the MD-120 100 mg group to the placebo group was not verified. A post-hoc analysis without multiplicity adjustment showed no statistically significant differences from the placebo group in the MD-120 100 mg group. As for safety, there were no events that greatly affected the tolerability.

No

Yamamuro Takuya

Mochida Pharmaceutical Co., Ltd.

7, Yotsuya 1-chome, Shinjuku-ku, Tokyo

clinical.trials.contact@mochida.co.jp

Public relations

Mochida Pharmaceutical Co., Ltd.

7, Yotsuya 1-chome, Shinjuku-ku, Tokyo

+81-3-3225-6303

webmaster@mochida.co.jp

completed

May. 18, 2020

Interventional

A randomized, parallel-group, multicenter, double-blind, placebo-controlled study

treatment purpose

3

1. Patient with diagnosis of MDD based on the criteria in the DSM-5.
2. HAMD17 total score of >=20.
Etc.

1. 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)
2. Patient who had suicidal behavior in C-SSRS within 1 year before start of screening phase.
Etc.

Both

MDD

investigational material(s)
Generic name etc : MD-120
INN of investigational material : desvenlafaxine
Therapeutic category code : 117 Psychotropic agents
Dosage and Administration for Investigational material : once-daily oral administration of MD-120 50mg or 100 mg

control material(s)
Generic name etc : placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : once-daily oral administration of placebo

Efficacy
-Change from baseline in MADRS total score
Safety
-AEs

Efficacy
-Change from baseline in HAMD17 total score
Safety
-ADRs
Pharmacokinetics
-Plasma concentration of desvenlafaxine

+81-3-6665-0572

April. 24, 2020