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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
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:

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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change from randomization in the HAM-A total score at Day 57

Secondary Outcome Measures :
  1. Change from randomization in CGI-S score at Day 57

Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Willie Earley, MD AstraZeneca
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by AstraZeneca:
GAD
anxiety
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs