Trial Registration: NCT00536471 (http://www.clinicaltrials.gov).
Assessment of depressive symptoms and functional outcomes in patients with major depressive disorder treated with duloxetine versus placebo: primary outcomes from two trials conducted under the same protocol
Article first published online: 13 JAN 2012
Copyright © 2012 John Wiley & Sons, Ltd.
Human Psychopharmacology: Clinical and Experimental
Volume 27, Issue 1, pages 47–56, January 2012
How to Cite
Oakes, T. M. M., Myers, A. L., Marangell, L. B., Ahl, J., Prakash, A., Thase, M. E. and Kornstein, S. G. (2012), Assessment of depressive symptoms and functional outcomes in patients with major depressive disorder treated with duloxetine versus placebo: primary outcomes from two trials conducted under the same protocol. Hum. Psychopharmacol. Clin. Exp., 27: 47–56. doi: 10.1002/hup.1262
- Issue published online: 25 JAN 2012
- Article first published online: 13 JAN 2012
- Manuscript Accepted: 20 NOV 2011
- Manuscript Received: 11 JUL 2011
Return of functional ability is a central goal in the treatment of major depressive disorder. We conducted two trials with the same protocol that was designed to assess functioning after 8 Weeks of treatment with duloxetine.
The a priori primary outcome was improvement in the Hamilton Depression Rating Scale (HAMD) item 7 (work/activities). Secondary outcomes included improvement in depressive symptoms assessed by the HAMD Maier subscale, and improvement in functioning assessed by the Sheehan Disability Scale (SDS), and the Social Adaptation Self-evaluation Scale (SASS). Patients were randomly assigned to duloxetine 60 mg/day (Trial I, n = 257; Trial II, n = 261) or placebo (Trial I, n = 127; Trial II, n = 131). Changes from baseline were analyzed using a mixed-effects model repeated measures approach.
At Week 8, duloxetine was superior to placebo in improving HAMD work/activities (p < 0.001) in Trial II, but not Trial I (p = 0.051), and Maier scores (p < 0.01) in both trials. At Week 12, duloxetine was superior to placebo on improving SASS scores in both trials, and the SDS in Trial II.
Treatment with duloxetine was associated with significant improvement in depressive symptoms compared with placebo, but improvement in HAMD work/activities was inconsistent at 8 weeks. Copyright © 2012 John Wiley & Sons, Ltd.