Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Generalized Anxiety Disorder (TITANIUM)
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|ClinicalTrials.gov Identifier: NCT00329264|
Recruitment Status : Completed
First Posted : May 24, 2006
Last Update Posted : March 25, 2009
The purpose of this study is to demonstrate that quetiapine SR (SEROQUEL®) is efficacious and safe in the acute treatment of patients with Generalized Anxiety Disorder.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
|Condition or disease||Intervention/treatment||Phase|
|Generalized Anxiety Disorder||Drug: Quetiapine fumarate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||876 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (SEROQUEL®) Compared With Placebo in the Treatment of Generalized Anxiety Disorder|
|Study Start Date :||April 2006|
|Actual Study Completion Date :||August 2007|
- Change from randomization in the HAM-A total score at Day 57
- Change from randomization in CGI-S score at Day 57
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): NCT00329264
|Study Director:||Willie Earley, MD||AstraZeneca|