Efficacy and Safety Study of Seroquel SR in the Treatment of Generalized Anxiety Disorder (SILVER)
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ClinicalTrials.gov Identifier: NCT00322595 |
Recruitment Status :
Completed
First Posted : May 8, 2006
Last Update Posted : December 22, 2008
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Generalized Anxiety Disorder | Drug: Quetiapine fumarate Drug: Paroxetine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 800 participants |
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) |
Study Start Date : | May 2006 |
Actual Study Completion Date : | May 2007 |
- 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).
- To evaluate efficacy by evaluating response rate.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322595

Study Director: | Seroquel Medical Science Director | AstraZeneca |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00322595 |
Other Study ID Numbers: |
D1448C00011 2005-005054-46 Silver |
First Posted: | May 8, 2006 Key Record Dates |
Last Update Posted: | December 22, 2008 |
Last Verified: | December 2007 |
Anxiety GAD |
Anxiety Disorders Mental Disorders Quetiapine Fumarate Paroxetine Antidepressive Agents Psychotropic Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs |
Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Antidepressive Agents, Second-Generation Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors |