Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling
This study has been completed.
Information provided by:
First received: November 15, 2005
Last updated: December 14, 2007
Last verified: December 2007
The purpose of the study is to evaluate the efficacy of quetiapine compared to valproate during a 12 month treatment period in subjects with Bipolar Disorder I or II with Rapid Cycling.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
Drug Information available for: Valproic acid Valproate sodium Divalproex sodium Quetiapine Quetiapine fumarateU.S. FDA Resources
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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).
|Study Start Date:||January 2002|
|Study Completion Date:||March 2006|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254774
Sponsors and Collaborators
|Study Director:||AstraZeneca Germany Medical Director, MD||AstraZeneca|