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Clinical Trial Results:
Prospective, double-blind, randomized, placebo-controlled dose finding study of the efficacy and safety of 2 target doses of Org 34517 used as adjunctive therapy in subjects with psychotic major depression (major depressive episode, severe, with psychotic features)
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 | |
EudraCT number | 2004-000050-23 |
Trial protocol | CZ GB |
Global completion date | 17 Jul 2006 |
| Paediatric regulatory details | |
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 |
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? | No |
| Results information | |
Results version number | v1(current) |
This version publication date | 16 Nov 2016 |
First version publication date | 16 Nov 2016 |
Other versions | |
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.