Clinical Trial Results:
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.
Summary
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EudraCT number |
2004-004008-19 |
Trial protocol |
GB IT ES |
Global completion date |
14 Mar 2008
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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
|
First version publication date |
03 May 2014
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Other versions |
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Summary report(s) |
Synopsis dated 10 march 2009 |
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.