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A Phase 4, 8-Week, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of Duloxetine 60 mg Once Daily in Outpatients with Major Depressive Disorder and Associated Painful Physic...

Update Il y a 5 ans
Reference: EUCTR2009-014605-14

A Phase 4, 8-Week, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of Duloxetine 60 mg Once Daily in Outpatients with Major Depressive Disorder and Associated Painful Physical Symptoms

Woman and Man

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Extract

The primary objective of this study is to test the hypothesis that duloxetine given 60 mg (30 mg for first week) once daily (QD), orally, for 8 weeks is superior to placebo QD, orally, for 8 weeks in the treatment of adult outpatients with MDD and associated painful physical symptoms. The primary objective will be evaluated from 2 perspectives: the reduction of pain severity and the improvement in depressive symptoms.

Inclusion criteria

  • Major Depressive Disorder

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