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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00108836

Collaborator

(none)

400

Enrollment

Locations

Duration (Months)

17.4

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders	Drug: XBD173	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2005

Actual Study Completion Date :

May 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site	Anaheim	California	United States	92801
2	Investigational Site	Los Angeles	California	United States	90024
3	Investigational Site	Newport Beach	California	United States	92660
4	Investigational Site	Redlands	California	United States	92374
5	Investigational Site	San Diego	California	United States	92108
6	Investigational Site	Ft. Meyers	Florida	United States	33712
7	Investigational Site	St. Petersburg	Florida	United States	33702
8	Investigational Site	West Palm Beach	Florida	United States	33407
9	Investigational Site	Atlanta	Georgia	United States	30308
10	Investigational Site	Hoffman Estates	Illinois	United States	60194
11	Investigational Site	Oak Brook	Illinois	United States	60523
12	Investigational Site	Overland Park	Kansas	United States	66211
13	Investigational Site	Dayton	Ohio	United States	45408
14	Investigational Site	Portland	Oregon	United States	97239
15	Investigational Site	Madison	Tennessee	United States	37115
16	Investigational Site	Memphis	Tennessee	United States	38119
17	Investigational Site	Edmonton	Alberta	Canada	T6G 2C8
18	Investigational Site	Kelowna	British Columbia	Canada	V1Y 2H4
19	Investigational Site	Hamilton	Ontario	Canada	3Z5
20	Investigational Site	Ottawa	Ontario	Canada	7K4
21	Investigational Site	Toronto	Ontario	Canada	1R8
22	Investigational Site	Montreal	Quebec	Canada	2N6
23	Investigational Site	Sherbrooke	Quebec	Canada	4J6