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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.
Servier Protocol Code:
CL3-20098-047
Sponsor:
Institut de Recherches Internationales Servier (I.R.I.S)
EudraCT Number:
2005-004881-17
Find a recruiting site
Name:
Institut de Recherches Internationales Servier, Département des études cliniques
Phone number:
+33 1 55 72 60 00
Results
English (USA)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.
- CL3-20098-047