Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo & Active Control in Generalized Anxiety Disorder

AstraZeneca800 enrolled

Overview

The purpose of this study is to demonstrate that quetiapine SR (SEROQUEL®) is efficacious and safe in the acute treatment of patients with Generalized Anxiety Disorder. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

800

Conditions

Generalized Anxiety Disorder

Interventions

Quetiapine FumarateDRUG

Escitalopram oxylateDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient has a documented clinical diagnosis of Generalized Anxiety Disorder. * Be able to understand and comply with the requirements of the study. * Able to understand and provide written informed consent Exclusion Criteria: * Patients (female) must not be pregnant or lactating * Current or past diagnosis of stroke or transient ischemic attack (TIA).

Locations (63)

Outcomes

Primary Outcomes

Change from randomization in the HAM-A total score at Day 57

Secondary Outcomes

Change from randomization in CGI-S score at Day 57

Data from ClinicalTrials.gov

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Research Site

Birmingham, Alabama, United States

Research Site

Scottsdale, Arizona, United States

Research Site

Little Rock, Arkansas, United States

Research Site

Beverly Hills, California, United States

Research Site

Burbank, California, United States

Research Site

La Mesa, California, United States

Research Site

Orange, California, United States

Research Site

Pasadena, California, United States

Research Site

San Diego, California, United States

Research Site

Sherman Oaks, California, United States

...and 53 more locations