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

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00322595

Acronym

SILVER

Enrollment

800

Registered

2006-05-08

Start date

2006-05-31

Completion date

2007-05-31

Last updated

2008-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Anxiety Disorder

Keywords

Anxiety, GAD

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.

Interventions

DRUGQuetiapine fumarate

DRUGParoxetine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To evaluate efficacy by evaluating response rate.	—

Countries

Argentina, Bulgaria, Canada, Czechia, Denmark, Finland, France, Germany, Mexico, Norway, Romania, Slovakia, South Africa, Spain, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026