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Date:12/10/2008

taking duloxetine experienced less worsening in symptom severity during the 52-week maintenance phase as measured by efficacy measures including the HAMD17 total score and subscales, the CGI-S and the Patient's Global Impression of Improvement (PGI-I) scales, compared with those taking placebo (p-values < .01). -- Patients taking duloxetine experienced a similar worsening in somatic symptom severity during the 52-week maintenance phase as measured by Visual Analog Scales (VAS) for pain and the Symptom Questionnaire- Somatic Subscale (SQ-SS), compared with those taking placebo (p-values > .05). -- The proportion of duloxetine-treated patients who discontinued the study due to adverse events during the acute, continuation and maintenance phases was 6.6 percent, 6.1 percent and 4.1 percent, respectively. The following were the most common treatment-emergent adverse events: - Acute phase: nausea, headache, dry mouth and excessive sweating -- In addition, there was one person who did not complete the acute phase due to a completed suicide, which was determined by study investigators not to be attributed to treatment. - Continuation phase: headache, common cold and excessive sweating - Maintenance phase: headache, back pain and common cold

Methods

The 52-week maintenance phase was preceded by up to 34-weeks of open-label treatment with duloxetine 60-120 mg once daily. Of the 514 patients initially entered into the study, 288 patients met response criteria at the end of up to 34 weeks treatment and were entered into the 52-week, double-blind, maintenance phase of the study. During the maintenance phase, patients were randomly assigned to receive either duloxetine at the dose to which they had previously responded, or placebo.

The primary endpoint
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SOURCE Eli Lilly and Company
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