Clinical Trial Results:
Efficacy and safety of 3 dose regimens of agomelatine (10, 25, 25-50 mg) versus placebo given once a day for 6 weeks in out-patients suffering from moderate to severe Major Depressive Disorder. A 6-week randomised, double-blind, placebo-controlled, parallel groups study followed by a double-blind optional 18-week extension period.
Summary
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EudraCT number |
2009-011238-84 |
Trial protocol |
SK BG FI |
Global completion date |
11 May 2012
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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 november 2012 |
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.