Time to response for duloxetine 60 mg once daily versus placebo in elderly patients with major depressive disorder.

Author(s): Raskin J, Xu JY, Kajdasz DK

Affiliation(s): Lilly Research Laboratories, Eli Lilly Canada, Toronto, Ontario, Canada. raskin_joel@lilly.com

Publication date & source: 2008-04, Int Psychogeriatr., 20(2):309-27. Epub 2007 Jun 22.

Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: Rapid response to antidepressant therapy is desirable and may be particularly critical in elderly patients with major depressive disorder (MDD).METHODS: Findings are based on post-hoc analyses from a double-blind trial of elderly patients with MDD > or = 65 years, randomly assigned 2:1 to duloxetine 60 mg QD (N = 207) or placebo (N = 104) for 8 weeks. Depression and pain measures included the Geriatric Depression Scale (GDS), 17-item Hamilton Depression Scale (HAMD17), CGI-Severity, and Visual Analog Scale (VAS) for overall pain. The time to response and remission for duloxetine compared with placebo was evaluated using Cox proportional hazards (PH) modeling, Kaplan-Meier estimation, and categorical repeated measures analysis.RESULTS: Significant improvements of estimated HAMD17 response and remission rates for duloxetine started at week 2 (P = 0.022 and P = 0.033, respectively). Time to HAMD17 response and remission were significantly shorter for duloxetine versus placebo (P 0.10 for all PH treatment-by-age interactions). The placebo-referenced duloxetine HR for time to 50% reduction in overall pain was 1.75 (P = 0.024) for patients with moderate to severe pain.CONCLUSION: Duloxetine demonstrated a faster time to antidepressant response and improvement in self-reported pain as compared with placebo.CLINICAL TRIAL REGISTRY NUMBER FOR THIS STUDY: NCT00062673, at www.clinicaltrials.gov.