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Home » Find Clinical Trials » 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.

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

Indication	Major Depressive Disorder

Sponsor	Institut de Recherches Internationales Servier (I.R.I.S)

Active substance/ Medical device	AGOMELATINE, S020098

Active Substance Code	S020098

Protocol Code	CL3-20098-076

EudraCT Code	2015-002181-23

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.