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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: May 5, 2006
Last updated: December 18, 2008
Last verified: December 2007

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
Intervention Model: Parallel Assignment
Masking: Double
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:

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00322595

  Show 89 Study Locations
Sponsors and Collaborators
Study Director: Seroquel Medical Science Director AstraZeneca
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00322595     History of Changes
Other Study ID Numbers: D1448C00011
Study First Received: May 5, 2006
Last Updated: December 18, 2008

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Anxiety Disorders
Pathologic Processes
Mental Disorders
Quetiapine Fumarate
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 processed this record on August 17, 2017