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

AstraZeneca876 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

876

Conditions

Generalized Anxiety Disorder

Interventions

Quetiapine fumarateDRUG

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 (58)

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

Springdale, Arizona, United States

Research Site

Little Rock, Arkansas, United States

Research Site

Encino, California, United States

Research Site

Newport Beach, California, United States

Research Site

Oceanside, California, United States

Research Site

Redlands, California, United States

Research Site

Santa Ana, California, United States

Research Site

Denver, Colorado, United States

Research Site

Norwich, Connecticut, United States

Research Site

Washington D.C., District of Columbia, United States

...and 48 more locations