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Efficacy and safety of 3 dose regimens of agomelatine (10, 25, 25-50 mg) versus placebo given once a day for 6 weeks in out-patients suffering from moderate to severe Major Depressive Disorder. A 6-week randomised, double-blind, placebo-controlled, parallel groups study followed by a double-blind optional 18-week extension period.


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Study Phase

Phase 3

Therapeutic Area

Neuropsychiatric Diseases

Active substance/
Medical device

S020098, AGOMELATINE

SponsorInstitut de Recherches Internationales Servier (I.R.I.S)
Active Substance CodeS020098
Protocol CodeCL3-20098-069
EudraCT Code2009-011238-84
ISRCTN CodeISRCTN10845256


Documents and links

Results summary READ MORE
Scientific publication READ MORE




Servier Glossary of Terms

To ease the reading, we are developing a glossary of terms. In this glossary, we provide the lay terms used in our lay summaries and the corresponding medical terms. You will find the Servier Glossary of Terms on this link.



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