Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Generalized Anxiety Disorder (TITANIUM)
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ClinicalTrials.gov Identifier: NCT00329264 |
Recruitment Status :
Completed
First Posted : May 24, 2006
Last Update Posted : March 25, 2009
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Generalized Anxiety Disorder | Drug: Quetiapine fumarate | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 876 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (SEROQUEL®) Compared With Placebo in the Treatment of Generalized Anxiety Disorder |
Study Start Date : | April 2006 |
Actual Study Completion Date : | August 2007 |
- Change from randomization in the HAM-A total score at Day 57
- Change from randomization in CGI-S score at Day 57

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329264

Study Director: | Willie Earley, MD | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00329264 |
Other Study ID Numbers: |
D1448C00009 Titanium |
First Posted: | May 24, 2006 Key Record Dates |
Last Update Posted: | March 25, 2009 |
Last Verified: | March 2009 |
GAD anxiety |
Anxiety Disorders Mental Disorders Quetiapine Fumarate Antidepressive Agents Psychotropic Drugs |
Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs |