A Comparison of Duloxetine Hydrochloride, Marketed Comparator, and Placebo in the Treatment of Generalized Anxiety Disorder
Phase 3
Completed
- Conditions
- Anxiety Disorders
- Registration Number
- NCT00122850
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This study will examine duloxetine compared with placebo and an active comparator in the treatment of generalized anxiety disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 480
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Self-reported anxiety symptomatology;Quality of Life;Clinical Global Improvement;HAMA factor scores
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
🇺🇸Seattle, Washington, United States