Generalized Anxiety Disorder Clinical Trial
— SILVEROfficial 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)
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.
Status | Completed |
Enrollment | 800 |
Est. completion date | May 2007 |
Est. primary completion date | |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Argentina, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Germany, Mexico, Norway, Romania, Slovakia, South Africa, Spain, Sweden,
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. |
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