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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00322595
First received: May 5, 2006
Last updated: December 18, 2008
Last verified: December 2007
History of Changes
  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
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):

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:
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 16, 2013