Clinical Trial Results:
Double-blind, placebo-controlled trial investigating the safety of re-exposure to 900 mg of Org 34517, used as adjunctive therapy in subjects with psychotic major depression (major depressive episode, severe, with psychotic features), who participated in Trial 28130
Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines
Summary
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EudraCT number |
2004-002156-34 |
Trial protocol |
CZ |
Global completion date |
16 Jun 2006
|
Paediatric regulatory details
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|
Is the trial part of an agreed EMA paediatric investigation plan? |
No
|
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 |
This version publication date |
13 Nov 2016
|
First version publication date |
13 Nov 2016
|
Other versions |
v2 |
Summary report(s) |
redacted synopsis |
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.