SCIENTIFIC DISCUSSION英文资料.pdfVIP

SCIENTIFIC DISCUSSION 1. Introduction Eli Lilly Netherlands B.V. has submitted a Marketing Authorisation Application through the Centralised Procedure, for the medicinal product CYMBALTA, containing duloxetine hydrochloride, for the treatment of major depressive episodes. This is a complete and independent marketing authorisation application, as stated in Art. 8 (3) of Directive 2001/83/EC, as amended. The provided data cover all aspects of the clinical characterization of safety and efficacy of duloxetine. The Applicant has submitted the results of non-clinical and clinical studies carried out for the application. Major Depressive disorder is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. Despite the availability of effective treatments, many persons with depressive disorders are disabled, and risk of suicide is considerable. It tends to be chronic and both relapse and recurrence are seen frequently. The diagnosis of major depression is based primarily on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria. The criteria state that at least five of the following symptoms must be present during the same period to receive a diagnosis of major depression: depressed mood, markedly diminished interest or pleasure in almost all activities (one of these two must be present necessary), significant weight loss/gain, insomnia/hypersomnia, psychomotor agitation/retardation, fatigue, feelings of worthlessness (guilt), impaired concentration and recurrent thoughts of death or suicide (American Psychiatric Association, 1994). The symptoms should be present most of the day, nearly daily, for