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

December 18, 2008 updated by: AstraZeneca

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)

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.

Study Overview

Status

Completed

Conditions

Generalized Anxiety Disorder

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina
    - Research Site
  - Cordoba, Argentina
    - Research Site
  - La Plata, Argentina
    - Research Site
  - Mendoza, Argentina
    - Research Site
- Buenos Aires
  - City Bell, Buenos Aires, Argentina
    - Research Site
- Mendoza
  - Godoy Cruz, Mendoza, Argentina
    - Research Site
- Santa Fe
  - Rosario, Santa Fe, Argentina
    - Research Site
Bulgaria
- - Kardjali, Bulgaria
    - Research Site
  - Ruse, Bulgaria
    - Research Site
  - Sofia, Bulgaria
    - Research Site
  - Varna, Bulgaria
    - Research Site
  - Veliko Tarnovo, Bulgaria
    - Research Site
  - Vratza, Bulgaria
    - Research Site
Canada
- British Columbia
  - Kelowna, British Columbia, Canada
    - Research Site
  - Vancouver, British Columbia, Canada
    - Research Site
- New Brunswick
  - Miramichi, New Brunswick, Canada
    - Research Site
- Newfoundland and Labrador
  - Corner Brook, Newfoundland and Labrador, Canada
    - Research Site
- Nova Scotia
  - Sydney, Nova Scotia, Canada
    - Research Site
- Ontario
  - Brantford, Ontario, Canada
    - Research Site
  - Chatham, Ontario, Canada
    - Research Site
  - Markham, Ontario, Canada
    - Research Site
  - Mississauga, Ontario, Canada
    - Research Site
  - Orleans, Ontario, Canada
    - Research Site
  - Ottawa, Ontario, Canada
    - Research Site
  - Toronto, Ontario, Canada
    - Research Site
- Quebec
  - Gatineau, Quebec, Canada
    - Research Site
  - Sherbrooke, Quebec, Canada
    - Research Site
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada
    - Research Site
Czech Republic
- - Brno, Czech Republic
    - Research Site
  - Litomerice, Czech Republic
    - Research Site
  - Olomouc, Czech Republic
    - Research Site
  - Plzen, Czech Republic
    - Research Site
  - Praha 10, Czech Republic
    - Research Site
  - Praha 2, Czech Republic
    - Research Site
  - Praha 5, Czech Republic
    - Research Site
  - Praha 6, Czech Republic
    - Research Site
  - Prerova, Czech Republic
    - Research Site
  - Prostojov, Czech Republic
    - Research Site
Denmark
- - Arhus, Denmark
    - Research Site
  - Frederiksberg, Denmark
    - Research Site
  - Kobenhavn, Denmark
    - Research Site
Finland
- - Helsinki, Finland
    - Research Site
  - Jarvenpaa, Finland
    - Research Site
  - Salo, Finland
    - Research Site
  - Turku, Finland
    - Research Site
France
- - Angouleme, France
    - Research Site
  - Arcachon, France
    - Research Site
  - Cherbourg, France
    - Research Site
  - Elancourt, France
    - Research Site
  - La Valette Du Var, France
    - Research Site
  - Le Pecq, France
    - Research Site
  - NIMES Cedex 4, France
    - Research Site
  - Rennes, France
    - Research Site
  - Toulouse, France
    - Research Site
Germany
- - Bad Saarow, Germany
    - Research Site
  - Berlin, Germany
    - Research Site
  - Bochum, Germany
    - Research Site
  - Göttingen, Germany
    - Research Site
  - Hamburg, Germany
    - Research Site
  - München, Germany
    - Research Site
  - Siegen, Germany
    - Research Site
Mexico
- - Distrito Federal, Mexico
    - Research Site
  - Guadalajara, Mexico
    - Research Site
  - Mexico, Mexico
    - Research Site
Norway
- - Brattvag, Norway
    - Research Site
  - Oslo, Norway
    - Research Site
  - Paradis, Norway
    - Research Site
Romania
- - Bucharest, Romania
    - Research Site
  - Pitesti, Romania
    - Research Site
  - Sibiu, Romania
    - Research Site
Slovakia
- - Bojnice, Slovakia
    - Research Site
  - Bratislava, Slovakia
    - Research Site
  - Brezno, Slovakia
    - Research Site
  - Kosice, Slovakia
    - Research Site
  - Liptovsky Mikulas, Slovakia
    - Research Site
  - Zilina-Bytcica, Slovakia
    - Research Site
South Africa
- - Bloemfontein, South Africa
    - Research Site
  - Cape Town, South Africa
    - Research Site
  - Durban, South Africa
    - Research Site
  - Pretoria, South Africa
    - Research Site
Spain
- - Barcelona, Spain
    - Research Site
  - Madrid, Spain
    - Research Site
  - Oviedo, Spain
    - Research Site
  - Salamanca, Spain
    - Research Site
Sweden
- - Linkoping, Sweden
    - Research Site
  - Lund, Sweden
    - Research Site
  - Malmo, Sweden
    - Research Site
  - Sundsvall, Sweden
    - Research Site
  - Uppsala, Sweden
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
To evaluate efficacy by evaluating response rate.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Study Director: Seroquel Medical Science Director, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

May 5, 2006

First Submitted That Met QC Criteria

May 5, 2006

First Posted (Estimate)

May 8, 2006

Study Record Updates

Last Update Posted (Estimate)

December 22, 2008

Last Update Submitted That Met QC Criteria

December 18, 2008

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Anxiety
GAD

Additional Relevant MeSH Terms

Other Study ID Numbers

D1448C00011
Silver
2005-005054-46

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.