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

of the study was time to recurrence of a major depressive episode during 52 weeks of maintenance treatment, as assessed by any of the following recurrence criteria: a CGI-S score greater than or equal to 4 and meeting DSM-IV criteria for major depressive disorder; three consecutive visits meeting re-emergence criteria or 10 total re-emergence visits; or study discontinuation due to lack of efficacy. Secondary measures included the HAMD17 total score and subscales, CGI-S and PGI-I scales, SQ-SS and VAS for pain. Safety and tolerability were assessed via analysis of treatment-emergent adverse events, vital signs, weight, ASEX for sexual functioning and laboratory measures. The primary study manuscript has already been submitted for review with a view to publication in a peer-reviewed medical journal.

About Duloxetine

Duloxetine is approved in the United States for the acute and maintenance treatment of major depressive disorder, the acute treatment of generalized anxiety disorder, and the management of diabetic peripheral neuropathic pain and fibromyalgia in adults aged 18 years and older. Duloxetine is not approved for use in pediatric patients.

Important Safety Information

Duloxetine is approved to treat major depressive disorder and generalized anxiety disorder, and to manage diabetic peripheral neuropathic pain and fibromyalgia. Antidepressants can increase suicidal thoughts and behaviors in children, adolescents, and young adults. Patients should call their doctor right away if they experience new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Be especially observant within the first few months of treatment or after a change in dose. Duloxetine is approved only for adults 18 and over.

Duloxetine is not for everyone. Patients should not take duloxetine if they have recently taken a type of antidepressant called a monoamine oxid
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SOURCE Eli Lilly and Company
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