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Home » Find Clinical Trials » Efficacy and safety of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally for 8 weeks in out-patients with severe Major Depressive Disorder. A randomised double-blind, parallel groups, international study versus fluoxetine (20 mg/day with potential adjustment to 40 mg) with a double-blind extension period of 16 weeks.

Efficacy and safety of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally for 8 weeks in out-patients with severe Major Depressive Disorder. A randomised double-blind, parallel groups, international study versus fluoxetine (20 mg/day with potential adjustment to 40 mg) with a double-blind extension period of 16 weeks.

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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	CL3-20098-045

EudraCT Code	2004-004008-19

ISRCTN Code	ISRCTN19313268

Documents and links

Results summary	READ MORE

Scientific publication	READ MORE

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