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

Condition(s) targeted: Generalized Anxiety Disorder

Intervention: Quetiapine fumarate (Drug); Paroxetine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Seroquel Medical Science Director, Study Director, Affiliation: AstraZeneca

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).

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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 outcome: To evaluate efficacy by evaluating response rate.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Research Site, Buenos Aires, Argentina

Research Site, CORDOBA, Argentina

Research Site, LA PLATA, Argentina

Research Site, Mendoza, Argentina

Research Site, Kardjali, Bulgaria

Research Site, Ruse, Bulgaria

Research Site, Sofia, Bulgaria

Research Site, Varna, Bulgaria

Research Site, VELIKO TARNOVO, Bulgaria

Research Site, VRATZA, Bulgaria

Research Site, Plzen, Czech Republic

Research Site, Brno, Czech Republic

Research Site, Litomerice, Czech Republic

Research Site, Olomouc, 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, Prostojov, Czech Republic

Research Site, Prerova, Czech Republic

Research Site, Arhus, Denmark

Research Site, Frederiksberg, Denmark

Research Site, Kobenhavn, Denmark

Research Site, Helsinki, Finland

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Research Site, CHERBOURG, France

Research Site, ELANCOURT, France

Research Site, LA VALETTE DU VAR, France

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Research Site, Oslo, Norway

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AstraZeneca Clinical Trial Information - Outside US

Starting date: May 2006
Ending date: May 2007
Last updated: December 13, 2007