Efficacy and Safety Study of Seroquel SR in the Treatment of Generalized Anxiety Disorder - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00322595

Purpose

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	Intervention	Phase
Generalized Anxiety Disorder	Drug: Quetiapine fumarate Drug: Paroxetine	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

Drug Information available for: Paroxetine Paroxetine hydrochloride Quetiapine Quetiapine fumarate Paroxetine Mesylate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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).

Secondary Outcome Measures:

To evaluate efficacy by evaluating response rate.

Estimated Enrollment:	800
Study Start Date:	May 2006
Study Completion Date:	May 2007

Eligibility

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

Criteria

Inclusion Criteria:

Male or female aged 18 to 65 years;
A diagnosis of generalized anxiety disorder;
Absence of current episode of major depression.

Exclusion Criteria:

The presence or history of schizophrenia and other psychotic disorders;
Hypertension;
A current diagnosis of cancer, unless in remission for at least 5 years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322595

Show 89 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Seroquel Medical Science Director

AstraZeneca

More Information

Additional Information:

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	D1448C00011, 2005-005054-46, Silver
Study First Received:	May 5, 2006
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00322595 History of Changes
Health Authority:	Denmark: Danish Medicines Agency; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Bulgaria: Bulgarian Drug Agency; Canada: Health Canada; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Finland: Finnish Medicines Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Mexico: Federal Commission for Protection Against Health Risks; Norway: Norwegian Medicines Agency; Romania: National Medicines Agency; Slovakia: State Institute for Drug Control; South Africa: Medicines Control Council; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

Anxiety
GAD

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
Paroxetine
Serotonin Uptake Inhibitors

Pharmacologic Actions
Quetiapine
Pathologic Processes
Serotonin Agents
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 08, 2010