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

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: Formic acid Paroxetine Quetiapine Quetiapine fumarate

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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Montgomery SA, Locklear JC, Svedsäter H, Eriksson H. Efficacy of once-daily extended release quetiapine fumarate in patients with different levels of severity of generalized anxiety disorder. Int Clin Psychopharmacol. 2014 Sep;29(5):252-62. doi: 10.1097/YIC.0000000000000026.

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. doi: 10.1002/hup.1256. 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. doi: 10.1017/S1461145709990423. 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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) 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:


Disease Anxiety Disorders Pathologic Processes Mental Disorders Quetiapine Fumarate Paroxetine Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs	Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Antidepressive Agents, Second-Generation Antidepressive Agents Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 30, 2016

Efficacy and Safety Study of Seroquel SR in the Treatment of Generalized Anxiety Disorder (SILVER)