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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00329446
First received: May 22, 2006
Last updated: March 24, 2009
Last verified: March 2009

May 22, 2006
March 24, 2009
April 2006
Not Provided
Change from randomization in the HAM-A total score at Day 57
Same as current
Complete list of historical versions of study NCT00329446 on ClinicalTrials.gov Archive Site
Change from randomization in CGI-S score at Day 57
Same as current
Not Provided
Not Provided
 
Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo & Active Control in Generalized Anxiety Disorder
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (SEROQUEL®) Compared With Placebo in the Treatment of Generalized Anxiety Disorder

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Generalized Anxiety Disorder
  • Drug: Quetiapine Fumarate
  • Drug: Escitalopram oxylate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
September 2007
Not Provided

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).
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00329446
D1448C00010, GOLD
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: Anders Neijber, MD AstraZeneca
AstraZeneca
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP