Duloxetine Hydrochloride 60 mg or 120 mg Once Daily Compared With Placebo in Patients With Generalized Anxiety Disorder.

Eli Lilly and Company1 site in 1 country480 target enrollmentJune 2004

ConditionsAnxiety Disorders

Drugsduloxetine hydrochloride placebo

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Anxiety Disorders
Sponsor: Eli Lilly and Company
Enrollment: 480
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a clinical trial assessing duloxetine compared with placebo in patients who have generalized anxiety disorder.

Registry

clinicaltrials.gov

Start Date

June 2004

End Date

September 2005

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

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•Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine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

Outcomes

Primary Outcomes

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.