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

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

This study has been completed.

First Received: May 22, 2006 Last Updated: March 24, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00329264

Purpose

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	Intervention	Phase
Generalized Anxiety Disorder	Drug: Quetiapine fumarate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Change from randomization in CGI-S score at Day 57

Estimated Enrollment:	876
Study Start Date:	April 2006
Study Completion Date:	August 2007

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329264

Show 58 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Willie Earley, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D1448C00009, Titanium
Study First Received:	May 22, 2006
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00329264 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

GAD
anxiety

Additional relevant MeSH terms:

Disease
Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions

Quetiapine
Pathologic Processes
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010