Clinical Trial Results:
Efficacy of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally on rest/activity circadian rhythms in outpatients with Major Depressive Disorder. A randomized, double-blind international study with parallel groups versus sertraline (50 mg/day with potential adjustment to 100 mg). Six-week treatment plus optional continuation for 18 weeks.
Summary
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EudraCT number |
2004-004009-10 |
Trial protocol |
DE AT IT ES |
Global completion date |
12 Mar 2007
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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 16 july 2008 |
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.