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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Generalized Anxiety Disorder

Treatments: Drug: Quetiapine fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00329264

Titanium

D1448C00009

Details and patient eligibility

About

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.

Enrollment: 876 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind