drugset / Trial / NCT01070329
A Study in Depression and Associated Painful Physical Symptoms
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2010-03
- Primary completion
- 2011-03
- Completion
- 2011-03
Publications
- Background Dmitrienko A, Offen WW, Westfall PH. Gatekeeping strategies for clinical trials that do not require all primary effects to be significant. Stat Med. 2003 Aug 15;22(15):2387-400. doi: 10.1002/sim.1526.
- Gaynor PJ, Gopal M, Zheng W, Martinez JM, Robinson MJ, Hann D, Marangell LB. Duloxetine versus placebo in the treatment of major depressive disorder and associated painful physical symptoms: a replication study. Curr Med Res Opin. 2011 Oct;27(10):1859-67. doi: 10.1185/03007995.2011.609540. Epub 2011 Aug 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Duloxetine | Small molecule | 60 mg | Oral |