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Efficacy and safety of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally for 8 weeks in out-patients with severe Major Depressive Disorder. A randomised double-blind, parallel groups, international study versus fluoxetine (20 mg/day with potential adjustment to 40 mg) with a double-blind extension period of 16 weeks.

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Study Phase

Phase 3

Therapeutic Area

Neuropsychiatric Diseases

IndicationMajor Depressive Disorder
SponsorInstitut de Recherches Internationales Servier (I.R.I.S)
Active substance/
Medical device


Active Substance CodeS020098
Protocol CodeCL3-20098-045
EudraCT Code2004-004008-19

Documents and links

Results summary READ MORE
Scientific publication READ MORE

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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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