Efficacy and Safety Study of Seroquel SR in the Treatment of Generalized Anxiety Disorder (SILVER)
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|ClinicalTrials.gov Identifier: NCT00322595|
Recruitment Status : Completed
First Posted : May 8, 2006
Last Update Posted : December 22, 2008
The primary purpose of this study is to evaluate the efficacy of (SEROQUEL SR™ ) quetiapine fumarate sustained-release (SR) compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD).
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 Drug: Paroxetine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||An International, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (Seroquel SR™ ) in the Treatment of Generalized Anxiety Disorder (SILVER)|
|Study Start Date :||May 2006|
|Actual Study Completion Date :||May 2007|
- To evaluate the efficacy compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD) at Day 57 (= end of treatment).
- To evaluate efficacy by evaluating response rate.
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): NCT00322595
|Study Director:||Seroquel Medical Science Director||AstraZeneca|