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Study Showed New Episodes of Depression Delayed in People Taking Cymbalta(R)
Date:12/10/2008

INDIANAPOLIS, Dec. 10 /PRNewswire-FirstCall/ -- New data suggest that Cymbalta (duloxetine HCl) 60 mg to 120 mg once daily delayed the onset of a new episode of depression in patients who had previously responded to the medication and who had recurrent depressive disorder, defined in the study as those patients who experienced at least three depressive episodes in the previous five years, compared with placebo (p < .001). Results from the 52- week maintenance phase of the longest controlled duloxetine study completed to date were presented at a meeting of a major scientific society today.

Additionally, patients who were treated with duloxetine were less likely (p < .001) to experience a new episode of depression than those who received placebo (recurrence rates were 14.4 percent vs. 33.1 percent, respectively).

Previous research has shown that up to 85 percent of patients with depression will experience depressive recurrences.(i) The number of episodes,(ii) their duration(iii) and the presence of lingering depressive symptoms increase the risk of recurrence, or future episodes of depression.(iv)

In the placebo-controlled maintenance phase of the study that followed initial open-label acute and continuation treatment phases, the most common adverse events (those occurring in at least 5 percent of patients in any treatment group) were headache, insomnia, dizziness, fatigue, back pain, common cold and flu.

    Additional Study Findings
    -- Time to worsening of depressive symptoms was significantly longer
       (p = .006) in the duloxetine-treated group compared with the placebo-
       treated group.  This was defined as a 50 percent increase from baseline
       on the 17-item Hamilton Rating Scale for Depression (HAMD17) total
       score and a Clinical Global Impressions of Severity (CGI-S) score of 3
       or more at anytime during the maintenance phase.
    -- Patients
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SOURCE Eli Lilly and Company
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