Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults.
Conditions
Brief summary
Change from the end of Phase A (Week 8 visit) to the end of Phase B (Week 14 visit) in the MADRS total score.
Detailed description
Standard safety variables to be examined in this trial will include AEs, physical examinations (including body weight and waist circumference), vital signs (blood pressure, heart rate, and body temperature), 12-lead ECGs, and clinical laboratory assessments (hematology, serum chemistry, urinalysis, prolactin, glycosylated hemoglobin, and coagulation parameters)., In addition to the standard safety variables, other safety variables including C-SSRS, SAS, AIMS, BARS, CSFQ, and PSQI will also be evaluated.
Interventions
DRUGVENLAFAXINE
DRUGESCITALOPRAM
DRUGUlotaront
DRUGSERTRALINE
DRUGDULOXETINE
DRUGFLUOXETINE
DRUGPAROXETINE
Sponsors
Otsuka Pharmaceutical Development And Commercialization Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from the end of Phase A (Week 8 visit) to the end of Phase B (Week 14 visit) in the MADRS total score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Standard safety variables to be examined in this trial will include AEs, physical examinations (including body weight and waist circumference), vital signs (blood pressure, heart rate, and body temperature), 12-lead ECGs, and clinical laboratory assessments (hematology, serum chemistry, urinalysis, prolactin, glycosylated hemoglobin, and coagulation parameters)., In addition to the standard safety variables, other safety variables including C-SSRS, SAS, AIMS, BARS, CSFQ, and PSQI will also be evaluated. | — |
Countries
Bulgaria, Czechia, Germany, Hungary, Poland, Spain
Outcome results
None listed