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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:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00322595
First received: May 5, 2006
Last updated: December 18, 2008
Last verified: December 2007
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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 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:
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) |
| Sexes Eligible for Study: | All |
| 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
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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
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:
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 |
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 June 23, 2017