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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 22, 2006

Last Updated Date

March 24, 2009

Start Date ^ICMJE

April 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Change from randomization in the HAM-A total score at Day 57

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00329446 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from randomization in CGI-S score at Day 57

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Generalized Anxiety Disorder

Intervention ^ICMJE

Drug: Quetiapine Fumarate
Drug: Escitalopram oxylate

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

800

Completion Date

September 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00329446

Other Study ID Numbers ^ICMJE

D1448C00010, GOLD

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Anders Neijber, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

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

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