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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00329446

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 Drug: Escitalopram oxylate	Phase III

MedlinePlus related topics: Anxiety

Drug Information available for: Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Quetiapine Quetiapine fumarate

U.S. FDA Resources

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

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:	800
Study Start Date:	April 2006
Study Completion Date:	October 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: NCT00329446

Show 63 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Anders Neijber, MD

AstraZeneca

More Information

Study ID Numbers:	D1448C00010, GOLD
Study First Received:	May 22, 2006
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00329446
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

GAD
anxiety

Study placed in the following topic categories:

Quetiapine
Anxiety Disorders
Mental Disorders

Dexetimide
Citalopram
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents

Serotonin Uptake Inhibitors
Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 15, 2009