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Home » Find Clinical Trials » 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.

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

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	CL3-20098-047

EudraCT Code	2005-004881-17

ISRCTN Code	ISRCTN28588282

Documents and links

Results summary	READ MORE

Scientific publication	READ MORE

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