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Clinical Trial Results:
An International, Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase III study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel™, single oral 300 mg or 600 mg dose) and Lithium as Monotherapy in Adult Patients with Bipolar Depression for 8 weeks and Quetiapine in Continuation Treatment for 26 up to 52 weeks.
| Summary | |
EudraCT number | 2004-004681-33 |
Trial protocol | LT LV EE DE |
Global completion date | 24 May 2007 |
| 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 | v2(current) |
This version publication date | 15 Dec 2016 |
First version publication date | 12 Aug 2016 |
Other versions | v1 |
Version creation reason |
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Summary report(s) | CSR-D1447C00001 |
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.