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

May 19, 2010 updated by: Novartis Pharmaceuticals
This study will test the efficacy, safety and tolerability of XBD173 in the treatment of generalized anxiety disorder in patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

400

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mean reduction in anxiety from baseline to week 6

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

April 19, 2005

First Submitted That Met QC Criteria

April 19, 2005

First Posted (Estimate)

April 20, 2005

Study Record Updates

Last Update Posted (Estimate)

May 20, 2010

Last Update Submitted That Met QC Criteria

May 19, 2010

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CXBD173A2204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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