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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

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


Active Substance CodeS020098
Protocol CodeCL3-20098-069
EudraCT Code2009-011238-84

Documents and links

Results summary READ MORE
Scientific publication READ MORE

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