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

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Quetiapine fumarate
Paroxetine
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Anxiety, GAD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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Outcomes

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.

Full Information

First Posted
May 5, 2006
Last Updated
December 18, 2008
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00322595
Brief Title
Efficacy and Safety Study of Seroquel SR in the Treatment of Generalized Anxiety Disorder
Acronym
SILVER
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 Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Anxiety, GAD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Quetiapine fumarate
Intervention Type
Drug
Intervention Name(s)
Paroxetine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To evaluate efficacy by evaluating response rate.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seroquel Medical Science Director
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
City Bell
State/Province
Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Godoy Cruz
State/Province
Mendoza
Country
Argentina
Facility Name
Research Site
City
Rosario
State/Province
Santa Fe
Country
Argentina
Facility Name
Research Site
City
Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Cordoba
Country
Argentina
Facility Name
Research Site
City
La Plata
Country
Argentina
Facility Name
Research Site
City
Mendoza
Country
Argentina
Facility Name
Research Site
City
Kardjali
Country
Bulgaria
Facility Name
Research Site
City
Ruse
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Varna
Country
Bulgaria
Facility Name
Research Site
City
Veliko Tarnovo
Country
Bulgaria
Facility Name
Research Site
City
Vratza
Country
Bulgaria
Facility Name
Research Site
City
Kelowna
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Miramichi
State/Province
New Brunswick
Country
Canada
Facility Name
Research Site
City
Corner Brook
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
Research Site
City
Sydney
State/Province
Nova Scotia
Country
Canada
Facility Name
Research Site
City
Brantford
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Chatham
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Markham
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Orleans
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Gatineau
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Research Site
City
Brno
Country
Czech Republic
Facility Name
Research Site
City
Litomerice
Country
Czech Republic
Facility Name
Research Site
City
Olomouc
Country
Czech Republic
Facility Name
Research Site
City
Plzen
Country
Czech Republic
Facility Name
Research Site
City
Praha 10
Country
Czech Republic
Facility Name
Research Site
City
Praha 2
Country
Czech Republic
Facility Name
Research Site
City
Praha 5
Country
Czech Republic
Facility Name
Research Site
City
Praha 6
Country
Czech Republic
Facility Name
Research Site
City
Prerova
Country
Czech Republic
Facility Name
Research Site
City
Prostojov
Country
Czech Republic
Facility Name
Research Site
City
Arhus
Country
Denmark
Facility Name
Research Site
City
Frederiksberg
Country
Denmark
Facility Name
Research Site
City
Kobenhavn
Country
Denmark
Facility Name
Research Site
City
Helsinki
Country
Finland
Facility Name
Research Site
City
Jarvenpaa
Country
Finland
Facility Name
Research Site
City
Salo
Country
Finland
Facility Name
Research Site
City
Turku
Country
Finland
Facility Name
Research Site
City
Angouleme
Country
France
Facility Name
Research Site
City
Arcachon
Country
France
Facility Name
Research Site
City
Cherbourg
Country
France
Facility Name
Research Site
City
Elancourt
Country
France
Facility Name
Research Site
City
La Valette Du Var
Country
France
Facility Name
Research Site
City
Le Pecq
Country
France
Facility Name
Research Site
City
NIMES Cedex 4
Country
France
Facility Name
Research Site
City
Rennes
Country
France
Facility Name
Research Site
City
Toulouse
Country
France
Facility Name
Research Site
City
Bad Saarow
Country
Germany
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Bochum
Country
Germany
Facility Name
Research Site
City
Göttingen
Country
Germany
Facility Name
Research Site
City
Hamburg
Country
Germany
Facility Name
Research Site
City
München
Country
Germany
Facility Name
Research Site
City
Siegen
Country
Germany
Facility Name
Research Site
City
Distrito Federal
Country
Mexico
Facility Name
Research Site
City
Guadalajara
Country
Mexico
Facility Name
Research Site
City
Mexico
Country
Mexico
Facility Name
Research Site
City
Brattvag
Country
Norway
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Paradis
Country
Norway
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Pitesti
Country
Romania
Facility Name
Research Site
City
Sibiu
Country
Romania
Facility Name
Research Site
City
Bojnice
Country
Slovakia
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Brezno
Country
Slovakia
Facility Name
Research Site
City
Kosice
Country
Slovakia
Facility Name
Research Site
City
Liptovsky Mikulas
Country
Slovakia
Facility Name
Research Site
City
Zilina-Bytcica
Country
Slovakia
Facility Name
Research Site
City
Bloemfontein
Country
South Africa
Facility Name
Research Site
City
Cape Town
Country
South Africa
Facility Name
Research Site
City
Durban
Country
South Africa
Facility Name
Research Site
City
Pretoria
Country
South Africa
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Oviedo
Country
Spain
Facility Name
Research Site
City
Salamanca
Country
Spain
Facility Name
Research Site
City
Linkoping
Country
Sweden
Facility Name
Research Site
City
Lund
Country
Sweden
Facility Name
Research Site
City
Malmo
Country
Sweden
Facility Name
Research Site
City
Sundsvall
Country
Sweden
Facility Name
Research Site
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
24394383
Citation
Montgomery SA, Locklear JC, Svedsater H, Eriksson H. Efficacy of once-daily extended release quetiapine fumarate in patients with different levels of severity of generalized anxiety disorder. Int Clin Psychopharmacol. 2014 Sep;29(5):252-62. doi: 10.1097/YIC.0000000000000026.
Results Reference
derived
PubMed Identifier
22143997
Citation
Stein DJ, Bandelow B, Merideth C, Olausson B, Szamosi J, Eriksson H. Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with generalised anxiety disorder: an analysis of pooled data from three 8-week placebo-controlled studies. Hum Psychopharmacol. 2011 Dec;26(8):614-28. doi: 10.1002/hup.1256. Epub 2011 Dec 6.
Results Reference
derived
PubMed Identifier
19691907
Citation
Bandelow B, Chouinard G, Bobes J, Ahokas A, Eggens I, Liu S, Eriksson H. Extended-release quetiapine fumarate (quetiapine XR): a once-daily monotherapy effective in generalized anxiety disorder. Data from a randomized, double-blind, placebo- and active-controlled study. Int J Neuropsychopharmacol. 2010 Apr;13(3):305-20. doi: 10.1017/S1461145709990423. Epub 2009 Aug 20.
Results Reference
derived

Learn more about this trial

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

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