Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo & Active Control in Generalized Anxiety Disorder - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 22, 2006

Last Updated Date

March 24, 2009

Start Date ^†

April 2006

Current Primary Outcome Measures ^†

Change from randomization in the HAM-A total score at Day 57

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00329446 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Change from randomization in CGI-S score at Day 57

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo & Active Control in Generalized Anxiety Disorder

Official Title ^†

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (SEROQUEL®) Compared With Placebo in the Treatment of Generalized Anxiety Disorder

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Generalized Anxiety Disorder

Intervention ^†

Drug: Quetiapine Fumarate
Drug: Escitalopram oxylate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Estimated Enrollment ^†

800

Completion Date

September 2007

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Patient has a documented clinical diagnosis of Generalized Anxiety Disorder.
Be able to understand and comply with the requirements of the study.
Able to understand and provide written informed consent

Exclusion Criteria:

Patients (female) must not be pregnant or lactating
Current or past diagnosis of stroke or transient ischemic attack (TIA).

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00329446

Responsible Party

Secondary IDs ^††

GOLD

Study Sponsor ^†

AstraZeneca

Collaborators ^††

Investigators ^†

Study Director:

Anders Neijber, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.