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Efficacy and safety of 2 doses of agomelatine (10mg, 25mg) given orally in children (from 7 to less than 12 years) and adolescents (from 12 to less than 18 years) with moderate to severe Major Depressive Disorder. A 12-week, randomized, double-blind, active (fluoxetine 10 mg/day with potential adjustment to 20 mg/day) and placebo-controlled, parallel groups, international, multicentre study followed by an optional open-labelled 21-month safety extension period.
Servier Protocol Code:
CL3-20098-076
Sponsor:
Institut de Recherches Internationales Servier (I.R.I.S)
EudraCT Number:
2015-002181-23
Find a recruiting site
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.
- CL3-20098-076