Conditions: Major Depressive Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 527
Healthy volunteers: no

Brief summary:
The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for 8 weeks to patients diagnosed with major depressive disorder, who also report associated painful physical symptoms, is better than placebo when treating depression and its associated painful symptoms.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Duloxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Participants received 30 milligrams (mg) duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase. intervention 2: Participants received placebo QD, po for 8 weeks, followed by placebo QD, po during the 2-week taper phase.

Protocol document: