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NCT00108836 Clinical Trial

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

Anxiety Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00108836
Other study ID # CXBD173A2204
Secondary ID
Status Completed
Phase Phase 2
First received April 19, 2005
Last updated May 19, 2010
Start date March 2005
Est. completion date May 2006

Study information
Verified date November 2007
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• XBD173

Locations
Country Name City State
Canada Investigational Site Edmonton Alberta
Canada Investigational Site Hamilton Ontario
Canada Investigational Site Kelowna British Columbia
Canada Investigational Site Montreal Quebec
Canada Investigational Site Ottawa Ontario
Canada Investigational Site Sherbrooke Quebec
Canada Investigational Site Toronto Ontario
United States Investigational Site Anaheim California
United States Investigational Site Atlanta Georgia
United States Investigational Site Dayton Ohio
United States Investigational Site Ft. Meyers Florida
United States Investigational Site Hoffman Estates Illinois
United States Investigational Site Los Angeles California
United States Investigational Site Madison Tennessee
United States Investigational Site Memphis Tennessee
United States Investigational Site Newport Beach California
United States Investigational Site Oak Brook Illinois
United States Investigational Site Overland Park Kansas
United States Investigational Site Portland Oregon
United States Investigational Site Redlands California
United States Investigational Site San Diego California
United States Investigational Site St. Petersburg Florida
United States Investigational Site West Palm Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean reduction in anxiety from baseline to week 6
Secondary The difference on day 4 in effect between placebo and the individual doses of XBD173 on reduction in anxiety and depression
Secondary Pharmacokinetic assessments at baseline
Secondary Pharmacogenetic assessments at baseline
Secondary Pharmacogenomic and proteomic assessments at baseline
Secondary Metabonomic assessments at visits 4, 7 and 10
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