"While depression in the elderly is very common, when other symptoms are present, like anxiety and cognitive deficits, treatment and diagnosis becomes that much more complicated," said lead investigator Joel Raskin, MD, Medical Advisor, Eli Lilly and Company, Indianapolis, Indiana, United States.

"Anxiety symptoms associated with depression increase the severity of depression and the risk of suicide, and cognitive deficits may appear, like a dementia," Dr. Raskin said. "In this study, patients taking Cymbalta saw an improvement in depression and anxiety symptoms as early as 1 week [post-treatment]."

Dr. Raskin and colleagues randomized subjects to 8 weeks of treatment with either duloxetine 60 mg (n = 207) or placebo (n = 104). The researchers analyzed the anxiety data as a whole and by age (207 under 75 years, and 96 over 75).

They evaluated efficacy for comorbid anxiety using changes from baseline to endpoint on the Hamilton Depression Scale (HAMD-17) item 10 (anxiety/ psychic), item 11 (anxiety/somatic) and items 10-13, 15 and 17 (the anxiety/somatization subscale).

Results show that subjects treated with duloxetine achieved greater reduction than those given placebo on the anxiety/ psychic subscale, with a mean decrease in scores of 0.62 and 0.18, respectively (P < .001) and on the anxiety/somatization subscale (mean change = -1.88 vs. -0.99, P = .002). Duloxetine did not result in improvement versus placebo on the anxiety/somatic subscale.

The separation between duloxetine and placebo began to be noticed at week 1 for item 10 and at week 4 for the anxiety/ somatization subscale.

Dr. Raskin reported statistically significant reductions in item 10 scores for the under 75 age group on duloxetine versus placebo (mean change = -0.63 vs. -0.17, P = .002) and the over 75 age group on duloxetine versus placebo (mean change = -0.61 vs. 0.00, P= .007).

Anxiety/somatization subscale scores decreased significantly for the under 75 age group on duloxetine versus placebo (mean change = -1.90 vs. -0.80, P = .003) but not for the over 75 duloxetine group versus placebo (mean change = -1.92 vs. -1.25, P = .312).

"Cymbalta was also effective in improving memory and attention in this population," Dr. Raskin added. "You can imagine how important that can be for an elderly person trying to maintain their independence."

The study was supported by Eli Lily and Company.


[Presentation title: NR478 Efficacy of Duloxetine for Anxiety in Elderly Patients With Major Depressive Disorder. Abstract NR478]

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