Clinical Trials Directory

Trials / Completed

CompletedNCT00322595

Efficacy and Safety Study of Seroquel SR in the Treatment of Generalized Anxiety Disorder

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)

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
800 (estimated)
Sponsor
AstraZeneca · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGQuetiapine fumarate
DRUGParoxetine

Timeline

Start date
2006-05-01
Completion
2007-05-01
First posted
2006-05-08
Last updated
2008-12-22

Locations

86 sites across 15 countries: Argentina, Bulgaria, Canada, Czechia, Denmark, Finland, France, Germany, Mexico, Norway, Romania, Slovakia, South Africa, Spain, Sweden

Source: ClinicalTrials.gov record NCT00322595. Inclusion in this directory is not an endorsement.