Anxiety Disorders
Conditions
Brief summary
This study will examine duloxetine compared with placebo and an active comparator in the treatment of generalized anxiety disorder.
Interventions
DRUGDuloxetine
DRUGvenlafaxine
DRUGplacebo
Sponsors
Boehringer Ingelheim
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
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, presenting with generalized anxiety disorder (GAD) based on the disease diagnostic criteria. Must suffer from GAD and not from an adjustment disorder or anxiety disorder not otherwise specified. The symptoms of GAD should not be situational in nature.
Exclusion criteria
* Any current and primary DSM-IV Axis I diagnosis other than GAD, including: * Patients diagnosed with major depressive disorder within the past 6 months; or * Patients diagnosed with panic disorder, or post-traumatic stress disorder within the past year; or * Patients diagnosed with obsessive-compulsive disorder, bipolar affective disorder, psychosis, factitious disorder, or somatoform disorders during their lifetimes. * The presence of an Axis II disorder or history of antisocial behavior, which, in the judgement of the investigator, would interfere with compliance with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess whether duloxetine hydrochloride 60 to 120 mg once daily is superior to placebo in the treatment of GAD during a 10-week, double-blind acute therapy phase, defined as statistically greater reduction in anxiety symptoms as measured by the HAMA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-reported anxiety symptomatology;Quality of Life;Clinical Global Improvement;HAMA factor scores | — |
Countries
United States
Outcome results
None listed