Anxiety Disorders
Conditions
Brief summary
This is a clinical trial assessing duloxetine compared with placebo in patients who have generalized anxiety disorder.
Interventions
DRUGduloxetine hydrochloride
DRUGplacebo
Sponsors
Boehringer Ingelheim
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female outpatients at least 18 years of age
Exclusion criteria
* Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine * Patient diagnosed with major depressive disorder within the past 6 months * Patient diagnosed with panic disorder, post-traumatic stress disorder, or an eating disorder within the past year * History of alcohol or any psychoactive substance abuse or dependence within the past 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess duloxetine 120 mg once daily is superior to placebo in the treatment of GAD, defined as statistically greater reduction on the mean change anxiety symptoms as measured by the HAMA total score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-reported anxiety symptomatology;Pain;Quality of Life;Clinical Global Improvement;HAMA factor scores | — |
Countries
Finland, France, Germany, South Africa, Spain, Sweden, United States
Outcome results
None listed