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


CONCLUSIONS
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.
Raskin
Joel
J
Lilly Research Laboratories, Eli Lilly Canada, Toronto, Ontario, Canada. raskin_joel@lilly.com
Xu
Jimmy Y
JY
Kajdasz
Daniel K
DK
D000368:Aged; D000369:Aged, 80 and over; D000928:Antidepressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000188:drug therapy*; D004334:Drug Administration Schedule; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D008297:Male; D013876:Thiophenes / Q000008:administration & dosage / Q000627:therapeutic use*; D013997:Time Factors
D000928:Antidepressive Agents; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride