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Efficacy and safety of 2 doses of agomelatine (10mg, 25mg) given orally in children (from 7 to less than 12 years) and adolescents (from 12 to less than 18 years) with moderate to severe Major Depressive Disorder. A 12-week, randomized, double-blind, active (fluoxetine 10 mg/day with potential adjustment to 20 mg/day) and placebo-controlled, parallel groups, international, multicentre study followed by an optional open-labelled 21-month safety extension period.

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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 CodeCL3-20098-076
EudraCT Code2015-002181-23

Documents and links

First lay summary
Second lay summary
First results summary READ MORE
Second 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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