Clinical Trial Results:
Evaluación de la eficacia y el beneficio clínico de agomelatina (25 a 50 mg/día) durante un período de tratamiento de 6 meses en pacientes con Trastorno Depresivo Mayor.Estudio aleatorizado, doble ciego, internacional multicéntrico con grupos paralelos versus duloxetina (60 mg/día). Veinticuatro semanas de tratamiento.//Evaluation of efficacy and clinical benefit of agomelatine (25 to 50 mg/day) over a 6-month treatment period in patients with Major Depressive Disorder.A randomised, double-blind, international multicentre study with parallel groups versus duloxetine (60 mg/day).Twenty-four weeks of treatment.
Summary
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EudraCT number |
2008-004642-92 |
Trial protocol |
ES PT HU IT GB |
Global completion date |
04 Aug 2010
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Jul 2016
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First version publication date |
03 May 2014
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Other versions |
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Summary report(s) |
Synopsis dated 23 september 2011 |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.