Anxiety Disorders
Conditions
Keywords
GAD, Anxiety, XBD173, Generalized Anxiety Disorder
Brief summary
This study will test the efficacy, safety and tolerability of XBD173 in the treatment of generalized anxiety disorder in patients.
Interventions
DRUGXBD173
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean reduction in anxiety from baseline to week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Canada, United States
Outcome results
None listed