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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329446

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

No publications provided by AstraZeneca

Additional 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
Study First Received: May 22, 2006
Last Updated: March 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
GAD
anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Dexetimide
Citalopram
Quetiapine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 17, 2014