Safety and Efficacy Maintenance Study of Quetiapine SR to Treat GAD Patients. - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00314210

Purpose

The primary objective of this study is to evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to an anxiety event in patients with generalised anxiety disorder (GAD).

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
Anxiety Disorders	Drug: Quetiapine SR	Phase III

MedlinePlus related topics: Anxiety

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Centre,Double-Blind,Randomised-Withdrawal,Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine SR as Monotherapy in the Maintenance Treatment of Patients With GAD Following an Open-Label Stabilisation Period

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Time from randomisation to occurrence of an anxiety event

Secondary Outcome Measures:

Occurrence of an anxiety event
Change from randomisation in HAM-A/CGI-S scores
In HAM-A psychic/somatic anxiety factor scores
In MADRS total score and in MADRS item 10 score (suicidal thought)
Change in Patient Reported Outcomes (PRO): QLESQ/PSQ/SDS

Estimated Enrollment:	575
Study Start Date:	March 2006
Study Completion Date:	October 2007

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients will be male or female, 18 to 65 years of age (inclusive), with a diagnosis of GAD according to DSM-IV criteria 300.02 as assessed by the MINI.

Exclusion Criteria:

Patients suffering from depressive symptoms, defined as having a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 17 or more at the enrolment visit, will be excluded from participation in this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314210

Show 115 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Martin Brecher, MD

AstraZeneca

More Information

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

Study ID Numbers:	D1448C00012, EUDRACT Number: 2005-005055-18
Study First Received:	April 11, 2006
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00314210
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Generalised Anxiety Disorder

Study placed in the following topic categories:

Quetiapine
Anxiety Disorders
Mental Disorders

Additional relevant MeSH terms:

Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009