Clinical trial NCT00108836: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anxiety Disorders
Keywords: GAD
Anxiety
XBD173
Generalized Anxiety Disorder
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-04-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Mean reduction in anxiety from baseline to week 6
Secondary outcomes:
measure: The difference on day 4 in effect between placebo and the individual doses of XBD173 on reduction in anxiety and depression
measure: Pharmacokinetic assessments at baseline
measure: Pharmacogenetic assessments at baseline
measure: Pharmacogenomic and proteomic assessments at baseline
measure: Metabonomic assessments at visits 4, 7 and 10
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Investigational Site
state: California
city: Los Angeles
country: United States
facility: Investigational Site
state: California
city: Newport Beach
country: United States
facility: Investigational Site
state: California
city: Redlands
country: United States
facility: Investigational Site
state: California
city: San Diego
country: United States
facility: Investigational Site
state: California
city: Ft. Meyers
country: United States
facility: Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Investigational Site
state: Georgia
city: Hoffman Estates
country: United States
facility: Investigational Site
state: Illinois
city: Oak Brook
country: United States
facility: Investigational Site
state: Illinois
city: Overland Park
country: United States
facility: Investigational Site
state: Kansas
city: Dayton
country: United States
facility: Investigational Site
state: Ohio
city: Portland
country: United States
facility: Investigational Site
state: Oregon
city: Madison
country: United States
facility: Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Investigational Site
state: Tennessee
city: Edmonton
country: Canada
facility: Investigational Site
state: Alberta
city: Kelowna
country: Canada
facility: Investigational Site
state: British Columbia
city: Hamilton
country: Canada
facility: Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Investigational Site
state: Quebec
Study officials:
References: