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

NCT ID: NCT00322595

Last Updated: 2008-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Generalized Anxiety Disorder

Keywords

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Anxiety GAD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Quetiapine fumarate

Intervention Type DRUG

Paroxetine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Seroquel Medical Science Director

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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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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Järvenpää, , 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

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Countries

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Greece Italy Turkey (Türkiye) Argentina Bulgaria Canada Czechia Denmark Finland France Germany Mexico Norway Romania Slovakia South Africa Spain Sweden

References

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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.

Reference Type DERIVED
PMID: 24394383 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22143997 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19691907 (View on PubMed)

Other Identifiers

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2005-005054-46

Identifier Type: -

Identifier Source: secondary_id

Silver

Identifier Type: -

Identifier Source: secondary_id

D1448C00011

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Identifier Source: org_study_id