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Duloxetine hydrochloride is used for the acute and maintenance treatment of major depressive disorder in adults. Efficacy of duloxetine for the acute treatment of major depression has principally been established by 4 double-blind, placebo-controlled studies of weeks' duration in outpatient settings in adults. Efficacy of duloxetine for the maintenance treatment of major depressive disorder has been established in a randomized, placebo-controlled relapse prevention study in which adult outpatients who met DSM-IV criteria for major depressive disorder initially received duloxetine 60 mg once daily in a week, open-label acute phase. Patients who responded to treatment during the acute phase were then randomized to continue receiving duloxetine at the same dosage or to receive placebo for 26 weeks in the continuation phase.

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