Efficacy and Safety Study of Seroquel SR in the Treatment of Generalized Anxiety Disorder
SILVER
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)
3 other identifiers
interventional
800
15 countries
86
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2006
Shorter than P25 for phase_3
86 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 5, 2006
CompletedFirst Posted
Study publicly available on registry
May 8, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedDecember 22, 2008
December 1, 2007
May 5, 2006
December 18, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (1)
To evaluate efficacy by evaluating response rate.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female aged 18 to 65 years;
- A diagnosis of generalized anxiety disorder;
- Absence of current episode of major depression.
You may not qualify if:
- The presence or history of schizophrenia and other psychotic disorders;
- Hypertension;
- A current diagnosis of cancer, unless in remission for at least 5 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (86)
Research Site
City Bell, Buenos Aires, Argentina
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Godoy Cruz, Mendoza Province, Argentina
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Mendoza, Mendoza Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Buenos Aires, Argentina
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Córdoba, Argentina
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La Plata, Argentina
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Kardzhali, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Veliko Tarnovo, Bulgaria
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Vratsa, Bulgaria
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Miramichi, New Brunswick, Canada
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Corner Brook, Newfoundland and Labrador, Canada
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Sydney, Nova Scotia, Canada
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Brantford, Ontario, Canada
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Chatham, Ontario, Canada
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Markham, Ontario, Canada
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Mississauga, Ontario, Canada
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Orléans, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Gatineau, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Brno, Czechia
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Litoměřice, Czechia
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Olomouc, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Prerova, Czechia
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Prostojov, Czechia
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Aarhus, Denmark
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Copenhagen, Denmark
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Frederiksberg, Denmark
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Helsinki, Finland
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Jarvenpaa, Finland
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Salo, Finland
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Turku, Finland
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Angoulême, France
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Arcachon, France
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Cherbourg, France
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Élancourt, France
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La Valette-du-Var, France
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Le Pecq, France
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Nîmes, France
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Rennes, France
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Toulouse, France
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Bad Saarow, Germany
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Berlin, Germany
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Bochum, Germany
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Göttingen, Germany
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Hamburg, Germany
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München, Germany
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Siegen, Germany
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Distrito Federal, Mexico
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Guadalajara, Mexico
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México, Mexico
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Brattvåg, Norway
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Oslo, Norway
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Paradis, Norway
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Bucharest, Romania
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Piteşti, Romania
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Sibiu, Romania
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Bojnice, Slovakia
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Bratislava, Slovakia
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Brezno, Slovakia
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Košice, Slovakia
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Liptovský Mikuláš, Slovakia
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Zilina-Bytcica, Slovakia
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Bloemfontein, South Africa
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Cape Town, South Africa
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Durban, South Africa
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Pretoria, South Africa
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Barcelona, Spain
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Madrid, Spain
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Oviedo, Spain
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Salamanca, Spain
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Linköping, Sweden
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Lund, Sweden
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Malmo, Sweden
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Sundsvall, Sweden
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Uppsala, Sweden
Related Publications (3)
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.
PMID: 24394383DERIVEDStein 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.
PMID: 22143997DERIVEDBandelow 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.
PMID: 19691907DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Seroquel Medical Science Director
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 5, 2006
First Posted
May 8, 2006
Study Start
May 1, 2006
Study Completion
May 1, 2007
Last Updated
December 22, 2008
Record last verified: 2007-12