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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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 Paroxetine hydrochloride hemihydrate 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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Stein DJ, Bandelow B, Merideth C, Olausson B, Szamosi J, Eriksson H. Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with generalised anxiety disorder: an analysis of pooled data from three 8-week placebo-controlled studies. Hum Psychopharmacol. 2011 Dec;26(8):614-28. Epub 2011 Dec 6.

Bandelow B, Chouinard G, Bobes J, Ahokas A, Eggens I, Liu S, Eriksson H. Extended-release quetiapine fumarate (quetiapine XR): a once-daily monotherapy effective in generalized anxiety disorder. Data from a randomized, double-blind, placebo- and active-controlled study. Int J Neuropsychopharmacol. 2010 Apr;13(3):305-20. Epub 2009 Aug 20.

ClinicalTrials.gov Identifier:	NCT00322595 History of Changes
Other Study ID Numbers:	D1448C00011, 2005-005054-46, Silver
Study First Received:	May 5, 2006
Last Updated:	December 18, 2008
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:

Anxiety Disorders
Mental Disorders
Paroxetine
Quetiapine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents

Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 24, 2012