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

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
XBD173
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring GAD, Anxiety, XBD173, Generalized Anxiety Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigational Site
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  • Investigational Site

Outcomes

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

Full Information

First Posted
April 19, 2005
Last Updated
May 19, 2010
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00108836
Brief Title
Efficacy, Safety and Tolerability of XBD173 in Patients With Generalized Anxiety Disorder
Official Title
Efficacy, Safety and Tolerability of XBD173 in Patients With Generalized Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
GAD, Anxiety, XBD173, Generalized Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
XBD173
Primary Outcome Measure Information:
Title
Mean reduction in anxiety from baseline to week 6
Secondary Outcome Measure Information:
Title
The difference on day 4 in effect between placebo and the individual doses of XBD173 on reduction in anxiety and depression
Title
Pharmacokinetic assessments at baseline
Title
Pharmacogenetic assessments at baseline
Title
Pharmacogenomic and proteomic assessments at baseline
Title
Metabonomic assessments at visits 4, 7 and 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Investigational Site
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Investigational Site
City
Ft. Meyers
State/Province
Florida
ZIP/Postal Code
33712
Country
United States
Facility Name
Investigational Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33702
Country
United States
Facility Name
Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Investigational Site
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
Facility Name
Investigational Site
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Investigational Site
City
Madison
State/Province
Tennessee
ZIP/Postal Code
37115
Country
United States
Facility Name
Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
Investigational Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 2H4
Country
Canada
Facility Name
Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
3Z5
Country
Canada
Facility Name
Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
7K4
Country
Canada
Facility Name
Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
1R8
Country
Canada
Facility Name
Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
2N6
Country
Canada
Facility Name
Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
4J6
Country
Canada

12. IPD Sharing Statement

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

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