Conditions: Major Depressive Disorder (MDD)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 249
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess nausea severity in response to four different drug dosing strategies of Duloxetine (30 mg with food, 60 mg with food, 30 mg without food, and 60 mg without food) in Korean patients with major depressive disorder (MDD).

Detailed description:

Arms:
arm 1: Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks arm 2: Duloxetine 60 mg capsule po QD without food for 8 weeks arm 3: Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks arm 4: Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks

Interventions: intervention 1: Duloxetine hydrochloride
Intervention descriptions: intervention 1: po, QD

Protocol document: