Generalized Anxiety Disorder Adjunct Study - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00534599

Purpose

This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL) when added to standard selective serotonin reuptake inhibitor (SSRI) / serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the treatment of Generalized Anxiety Disorder in patients with partial or no response to SSRI/SNRI alone or in combination with a benzodiazepine, and if so, how it compares with placebo

Condition	Intervention	Phase
Anxiety Anxiety Disorders Anxiety Neuroses Anxiety States	Drug: quietipine fumarate XR Drug: Benzodiazepine	Phase III

MedlinePlus related topics: Anxiety

Drug Information available for: Quetiapine fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Rand., Double-Blind, Parallel-Group, Pbo-Controlled Study of the Efficacy and Safety of SEROQUEL® XR Compared With Pbo as an Adjunct to Treatment in Patients With Generalized Anxiety Disorder Who Demonstrate Partial or No Response to a SSRI or SNRI Alone or in Combination With a Benzo

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary obj. of this study is to evaluate the efficacy of (SEROQUEL® XR) compared to pbo when added to SSRI/SNRI therapy in treatment of anxiety in pts. with GAD with a history of partial or no response to SSRI/SNRI alone or in comb with benzo

Secondary Outcome Measures:

To evaluate the effect of quetiapine XR versus placebo when added to FDA-approved SSRI/SNRI therapy alone or in combination with a benzodiazepine on the health-related quality of life in patients with GAD

Estimated Enrollment:	410
Study Start Date:	August 2007
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Sham Comparator Placebo Seroquel XR + benzodiazepine	Drug: Benzodiazepine oral
2: Experimental Seroquel XR monotherapy + benzodiazepine placebo	Drug: quietipine fumarate XR oral
3: Experimental Seroquel XR + benzodiazepine	Drug: quietipine fumarate XR oral Drug: Benzodiazepine oral

Eligibility

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

Criteria

Inclusion Criteria:

Provision of Informed Consent

Documented diagnosis of Generalized Anxiety Disorder
Female patients must not be pregnant and be willing to use a reliable method of birth control
Be able to understand and comply with study requirements

Exclusion Criteria:

Other psychiatric disorders that could confound the study results, as judged by the study doctor

Moderate to severe depression
Other clinically relevant diseases, as judged by the study doctor
Medication that you are taking, as judged by the study doctor

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534599

Show 53 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Martin Brecher, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D1441L00016
Study First Received:	September 24, 2007
Last Updated:	January 23, 2009
ClinicalTrials.gov Identifier:	NCT00534599 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Generalized anxiety disorders
anxiety
adjunct treatment in anxiety
anxiety disorder
partial or non-responder in anxiety

Study placed in the following topic categories:

Quetiapine
Anxiety Disorders
Mental Disorders
Neurotic Disorders
Serotonin Uptake Inhibitors

Additional relevant MeSH terms:

Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders
Neurotic Disorders

ClinicalTrials.gov processed this record on May 07, 2009