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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Anxiety Disorders

Treatments: Drug: Placebo; Drug: Quetiapine XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00389064

D1448C00015

EUDRACT No: 2006-001195-21

Details and patient eligibility

About

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.

Enrollment: 450 patients

Sex: All

Ages: 66+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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450 participants in 2 patient groups, including a placebo group

Quetapine XR

Experimental group

Description:

Tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily.

Treatment:

Drug: Quetiapine XR

Placebo

Placebo Comparator group

Description:

Matching placebo tablets orally administered once daily.

Treatment:

Drug: Placebo