Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling
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|ClinicalTrials.gov Identifier: NCT00254774|
Recruitment Status : Completed
First Posted : November 17, 2005
Last Update Posted : December 18, 2007
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Drug: quetiapine fumarate or valproate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of the Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling: an Open Trial|
|Study Start Date :||January 2002|
|Actual Study Completion Date :||March 2006|
- Number of clinically relevant recurrences of depression or mania. Recurrence is defined by a change in LCM-C/P to moderate or severe or by 2 or more steps. End of an episode is defined as reduction to mild or baseline or by 2 or more steps.
- Absolute change from baseline on the (recalculated) HAM-D, YMRS, MADRS, total score. Absolute change from baseline on the CGI-BP severity score per dimension (mania, depression, overall bipolar illness).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00254774
|Study Director:||AstraZeneca Germany Medical Director, MD||AstraZeneca|