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

Generalized Anxiety Disorder Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322595
• Other study ID #: D1448C00011
• Secondary ID: 2005-005054-46Si
• Status: Completed
• Phase: Phase 3
• First received: May 5, 2006
• Last updated: December 18, 2008
• Start date: May 2006
• Est. completion date: May 2007

Study information

• Verified date: December 2007
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBulgaria: Bulgarian Drug AgencyCanada: Health CanadaCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Finland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesGreece: National Organization of MedicinesItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthMexico: Federal Commission for Protection Against Health RisksNorway: Norwegian Medicines AgencyRomania: National Medicines AgencySlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilSpain: Spanish Agency of MedicinesSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Drug:
• Quetiapine fumarate

• Paroxetine

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	City Bell	Buenos Aires
Argentina	Research Site	Cordoba
Argentina	Research Site	Godoy Cruz	Mendoza
Argentina	Research Site	La Plata
Argentina	Research Site	Mendoza
Argentina	Research Site	Rosario	Santa Fe
Bulgaria	Research Site	Kardjali
Bulgaria	Research Site	Ruse
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Varna
Bulgaria	Research Site	Veliko Tarnovo
Bulgaria	Research Site	Vratza
Canada	Research Site	Brantford	Ontario
Canada	Research Site	Chatham	Ontario
Canada	Research Site	Corner Brook	Newfoundland and Labrador
Canada	Research Site	Gatineau	Quebec
Canada	Research Site	Kelowna	British Columbia
Canada	Research Site	Markham	Ontario
Canada	Research Site	Miramichi	New Brunswick
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Orleans	Ontario
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Saskatoon	Saskatchewan
Canada	Research Site	Sherbrooke	Quebec
Canada	Research Site	Sydney	Nova Scotia
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
Czech Republic	Research Site	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
Denmark	Research Site	Arhus
Denmark	Research Site	Frederiksberg
Denmark	Research Site	Kobenhavn
Finland	Research Site	Helsinki
Finland	Research Site	Jarvenpaa
Finland	Research Site	Salo
Finland	Research Site	Turku
France	Research Site	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
Germany	Research Site	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
Mexico	Research Site	Distrito Federal
Mexico	Research Site	Guadalajara
Mexico	Research Site	Mexico
Norway	Research Site	Brattvag
Norway	Research Site	Oslo
Norway	Research Site	Paradis
Romania	Research Site	Bucharest
Romania	Research Site	Pitesti
Romania	Research Site	Sibiu
Slovakia	Research Site	Bojnice
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Brezno
Slovakia	Research Site	Kosice
Slovakia	Research Site	Liptovsky Mikulas
Slovakia	Research Site	Zilina-Bytcica
South Africa	Research Site	Bloemfontein
South Africa	Research Site	Cape Town
South Africa	Research Site	Durban
South Africa	Research Site	Pretoria
Spain	Research Site	Barcelona
Spain	Research Site	Madrid
Spain	Research Site	Oviedo
Spain	Research Site	Salamanca
Sweden	Research Site	Linkoping
Sweden	Research Site	Lund
Sweden	Research Site	Malmo
Sweden	Research Site	Sundsvall
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Argentina,  Bulgaria,  Canada,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Mexico,  Norway,  Romania,  Slovakia,  South Africa,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate efficacy by evaluating response rate.

External Links

•   AstraZeneca Clinical Trial Information - Outside US