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Efficacy and safety of 3 doses (0.25, 0.5 and 1mg/day) of agomelatine sublingual administration over an 8-week treatment period, in out-patients with Major Depressive Disorder. An 8-week randomised, double-blind, fixed dose, international multicentre, placebo-controlled study with parallel groups, followed by an extension double-blind treatment period of 16 weeks.

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Study Phase

Phase 2

Therapeutic Area

Neuropsychiatric Diseases

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


Active Substance CodeS090098
Protocol CodeCL2-90098-009
EudraCT Code2009-014045-92

Documents and links

Results summary READ MORE

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