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

Completed · Phase 3 · Has a placebo group

Conditions studied: Anxiety Disorders

In brief

The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve elderly patients with generalised anxiety disorder. PLEASE NOTE: Seroquel SR and Seroquel extended release(XR) refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Key facts

Study ID

NCT00389064

Run by

AstraZeneca

People needed

450

Starts

2006-09-01

Expected to finish

2008-04-01

Last updated by the study team

2012-04-04

Who can join

Age: 66 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients, 66 years or older, with a documented clinical diagnosis of Generalised Anxiety Disorder (GAD).
• Absence of current episode of major depression.

You may not qualify if…

• The presence of dementia or other mental disorder than GAD.
• Serious suicidal risk, uncontrolled hypertension, substance or alcohol abuse.
• A current diagnosis of cancer or current or past diagnosis of stroke.

Where it is running

• Research Site — Fort Myers, Florida, United States
• Research Site — Gainsville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Sarasota, Florida, United States
• Research Site — Roswell, Georgia, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Brooklyn, New York, United States
• Research Site — The Bronx, New York, United States
• Research Site — Avon Lake, Ohio, United States
• Research Site — Eugene, Oregon, United States
• Research Site — Jenkintown, Pennsylvania, United States
• Research Site — Austin, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Tartu, Estonia, Estonia
• Research Site — Tallinn, Estonia
• Research Site — Viljandi, Estonia
• Research Site — Bialystok, Poland
• Research Site — Gorlice, Poland
• Research Site — Katowice, Poland
• Research Site — Krakow, Poland
• Research Site — Leszno, Poland
• Research Site — Skorzewo, Poland
• Research Site — Torun, Poland
• Research Site — Wroclaw, Poland

Full record on ClinicalTrials.gov

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