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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:
ClinicalTrials.gov Identifier:
NCT00329446
First Posted: May 24, 2006
Last Update Posted: March 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose

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 Intervention Phase
Generalized Anxiety Disorder Drug: Quetiapine Fumarate Drug: Escitalopram oxylate Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change from randomization in the HAM-A total score at Day 57

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

Estimated Enrollment: 800
Study Start Date: April 2006
Study Completion Date: September 2007
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (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
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): NCT00329446


  Show 63 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Anders Neijber, MD AstraZeneca
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00329446     History of Changes
Other Study ID Numbers: D1448C00010
GOLD
First Submitted: May 22, 2006
First Posted: May 24, 2006
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
GAD
anxiety

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders
Citalopram
Quetiapine Fumarate
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants