Find Clinical Trial

Efficacy and safety of agomelatine (25 mg/day with potential adjustment at 50 mg/day) given orally compared to placebo, in addition to a mood stabilizer in Bipolar I patients with a current major depressive episode. An 8-week randomised, double-blind, controlled, parallel groups study followed by a double-blind extension treatment period up to 1 year.

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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 CodeCL3-20098-047
EudraCT Code2005-004881-17

Documents and links

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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