Generalized Anxiety Disorder Adjunct Study

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Anxiety Disorders; Anxiety; Anxiety Neuroses; Anxiety States

Treatments: Drug: Placebo; Drug: quetiapine fumarate XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00534599

D1441L00016

Details and patient eligibility

About

This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL) when added to standard selective serotonin reuptake inhibitor (SSRI) / serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the treatment of Generalized Anxiety Disorder in patients with partial or no response to SSRI/SNRI alone or in combination with a benzodiazepine, and if so, how it compares with placebo

Enrollment: 409 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Provision of Informed Consent

• Documented diagnosis of Generalized Anxiety Disorder
• Female patients must not be pregnant and be willing to use a reliable method of birth control
• Be able to understand and comply with study requirements

Exclusion criteria

Other psychiatric disorders that could confound the study results, as judged by the study doctor

• Moderate to severe depression
• Other clinically relevant diseases, as judged by the study doctor
• Medication that you are taking, as judged by the study doctor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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409 participants in 2 patient groups

1

Other group

Description:

Adjunctive Placebo Seroquel XR to anxiety treatment

Treatment:

Drug: Placebo

2

Experimental group

Description:

Adjunctive Seroquel XR to anxiety treatment

Treatment:

Drug: quetiapine fumarate XR