Efficacy, Safety and Tolerability of XBD173 in Patients With Generalized Anxiety Disorder - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00108836

Purpose

This study will test the efficacy, safety and tolerability of XBD173 in the treatment of generalized anxiety disorder in patients.

Condition	Intervention	Phase
Anxiety Disorders	Drug: XBD173	Phase II

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy, Safety and Tolerability of XBD173 in Patients With Generalized Anxiety Disorder

Further study details as provided by Novartis:

Primary Outcome Measures:

Mean reduction in anxiety from baseline to week 6

Secondary Outcome Measures:

The difference on day 4 in effect between placebo and the individual doses of XBD173 on reduction in anxiety and depression
Pharmacokinetic assessments at baseline
Pharmacogenetic assessments at baseline
Pharmacogenomic and proteomic assessments at baseline
Metabonomic assessments at visits 4, 7 and 10

Estimated Enrollment:	400
Study Start Date:	March 2005
Study Completion Date:	May 2006

Eligibility

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

Criteria

Inclusion Criteria:

Current doctor's diagnosis of generalized anxiety disorder
In need of psychiatric treatment
Willingness to complete all aspects of the study

Exclusion Criteria:

Current doctor's diagnosis of major depression
History of schizophrenia or schizoaffective disorders
Drug dependence within 2 months prior to study start

For detailed information on eligibility, please contact the study center nearest to you (see below), or call 1-862-778-8300, or visit the following website:

www.novartisclinicaltrials.com

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108836

Locations

United States, California
Investigational Site
Anaheim, California, United States, 92801
Investigational Site
San Diego, California, United States, 92108
Investigational Site
Los Angeles, California, United States, 90024
Investigational Site
Newport Beach, California, United States, 92660
Investigational Site
Redlands, California, United States, 92374
United States, Florida
Investigational Site
West Palm Beach, Florida, United States, 33407
Investigational Site
St. Petersburg, Florida, United States, 33702
Investigational Site
Ft. Meyers, Florida, United States, 33712
United States, Georgia
Investigational Site
Atlanta, Georgia, United States, 30308
United States, Illinois
Investigational Site
Hoffman Estates, Illinois, United States, 60194
Investigational Site
Oak Brook, Illinois, United States, 60523
United States, Kansas
Investigational Site
Overland Park, Kansas, United States, 66211
United States, Ohio
Investigational Site
Dayton, Ohio, United States, 45408
United States, Oregon
Investigational Site
Portland, Oregon, United States, 97239
United States, Tennessee
Investigational Site
Memphis, Tennessee, United States, 38119
Investigational Site
Madison, Tennessee, United States, 37115
Canada, Alberta
Investigational Site
Edmonton, Alberta, Canada, T6G 2C8
Canada, British Columbia
Investigational Site
Kelowna, British Columbia, Canada, V1Y 2H4
Canada, Ontario
Investigational Site
Ottawa, Ontario, Canada, 7K4
Investigational Site
Toronto, Ontario, Canada, 1R8
Investigational Site
Hamilton, Ontario, Canada, 3Z5
Canada, Quebec
Investigational Site
Sherbrooke, Quebec, Canada, 4J6
Investigational Site
Montreal, Quebec, Canada, 2N6

Sponsors and Collaborators

Novartis

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	CXBD173A2204
Study First Received:	April 19, 2005
Last Updated:	November 28, 2007
ClinicalTrials.gov Identifier:	NCT00108836
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

GAD
Anxiety
XBD173
Generalized Anxiety Disorder

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 15, 2009