Efficacy, Safety and Tolerability of XBD173 in Patients With Generalized Anxiety Disorder

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00108836
First received: April 19, 2005
Last updated: May 19, 2010
Last verified: November 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy, Safety and Tolerability of XBD173 in Patients With Generalized Anxiety Disorder

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Investigational Site
Anaheim, California, United States, 92801
Investigational Site
Los Angeles, California, United States, 90024
Investigational Site
Newport Beach, California, United States, 92660
Investigational Site
Redlands, California, United States, 92374
Investigational Site
San Diego, California, United States, 92108
United States, Florida
Investigational Site
Ft. Meyers, Florida, United States, 33712
Investigational Site
St. Petersburg, Florida, United States, 33702
Investigational Site
West Palm Beach, Florida, United States, 33407
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
Madison, Tennessee, United States, 37115
Investigational Site
Memphis, Tennessee, United States, 38119
Canada, Alberta
Investigational Site
Edmonton, Alberta, Canada, T6G 2C8
Canada, British Columbia
Investigational Site
Kelowna, British Columbia, Canada, V1Y 2H4
Canada, Ontario
Investigational Site
Hamilton, Ontario, Canada, 3Z5
Investigational Site
Ottawa, Ontario, Canada, 7K4
Investigational Site
Toronto, Ontario, Canada, 1R8
Canada, Quebec
Investigational Site
Montreal, Quebec, Canada, 2N6
Investigational Site
Sherbrooke, Quebec, Canada, 4J6
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00108836     History of Changes
Other Study ID Numbers: CXBD173A2204
Study First Received: April 19, 2005
Last Updated: May 19, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
GAD
Anxiety
XBD173
Generalized Anxiety Disorder

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 02, 2014