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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.
Servier Protocol Code:
CL3-20098-045
Sponsor:
Institut de Recherches Internationales Servier (I.R.I.S)
EudraCT Number:
2004-004008-19
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Name:
Institut de Recherches Internationales Servier, Département des études cliniques
Phone number:
+33 1 55 72 60 00
Results
Interventions / Treatments
The treatment(s) given to the participants in the study.
- Major Depressive Disorder
- AGOMELATINE
- S020098
Other study id numbers
Other identification numbers the study may be known by.
- CL3-20098-045