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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Generalized Anxiety Disorder

Treatments: Drug: Paroxetine; Drug: Quetiapine fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00322595

Silver

2005-005054-46

D1448C00011

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind