Clinical trial NCT00322595: Efficacy and Safety Study of Seroquel SR in the Treatment of Generalized Anxiety Disorder
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Generalized Anxiety Disorder
Keywords: Anxiety
GAD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-05-08
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

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