Efficacy, Safety and Tolerability of XBD173 in Patients With Generalized Anxiety Disorder
1 other identifier
interventional
400
2 countries
23
Brief Summary
This study will test the efficacy, safety and tolerability of XBD173 in the treatment of generalized anxiety disorder in patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2005
Shorter than P25 for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 19, 2005
CompletedFirst Posted
Study publicly available on registry
April 20, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedMay 20, 2010
November 1, 2007
April 19, 2005
May 19, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean reduction in anxiety from baseline to week 6
Secondary Outcomes (5)
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
Interventions
Eligibility Criteria
You may qualify if:
- Current doctor's diagnosis of generalized anxiety disorder
- In need of psychiatric treatment
- Willingness to complete all aspects of the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Investigational Site
Anaheim, California, 92801, United States
Investigational Site
Los Angeles, California, 90024, United States
Investigational Site
Newport Beach, California, 92660, United States
Investigational Site
Redlands, California, 92374, United States
Investigational Site
San Diego, California, 92108, United States
Investigational Site
Fort Meyers, Florida, 33712, United States
Investigational Site
St. Petersburg, Florida, 33702, United States
Investigational Site
West Palm Beach, Florida, 33407, United States
Investigational Site
Atlanta, Georgia, 30308, United States
Investigational Site
Hoffman Estates, Illinois, 60194, United States
Investigational Site
Oak Brook, Illinois, 60523, United States
Investigational Site
Overland Park, Kansas, 66211, United States
Investigational Site
Dayton, Ohio, 45408, United States
Investigational Site
Portland, Oregon, 97239, United States
Investigational Site
Madison, Tennessee, 37115, United States
Investigational Site
Memphis, Tennessee, 38119, United States
Investigational Site
Edmonton, Alberta, T6G 2C8, Canada
Investigational Site
Kelowna, British Columbia, V1Y 2H4, Canada
Investigational Site
Hamilton, Ontario, 3Z5, Canada
Investigational Site
Ottawa, Ontario, 7K4, Canada
Investigational Site
Toronto, Ontario, 1R8, Canada
Investigational Site
Montreal, Quebec, 2N6, Canada
Investigational Site
Sherbrooke, Quebec, 4J6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 19, 2005
First Posted
April 20, 2005
Study Start
March 1, 2005
Study Completion
May 1, 2006
Last Updated
May 20, 2010
Record last verified: 2007-11