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 Paroxetine
as Monotherapy in Adult Patients with Bipolar Depression for 8 weeks and
Quetiapine in Continuation Treatment for 26 up to 52 weeks.
Summary
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|
EudraCT number |
2004-004909-16 |
Trial protocol |
GB |
Global completion date |
31 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 |
07 Dec 2016
|
First version publication date |
12 Aug 2016
|
Other versions |
v1 |
Version creation reason |
|
Summary report(s) |
D1447C00134-CSR |
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.