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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
615
Mochida Investigational sites
Tokyo, Japan
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.