Duloxetine Compared With Placebo in Patients With Generalized Anxiety Disorder

Phase 3

Completed

• Conditions: Anxiety Disorders

• Registration Number: NCT00122824
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-07-20
• Study First Submitted QC: 2005-07-20
• Study First Posted: 2005-07-22
• Study Completion: 2005-09
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-05
• Last Update Posted: 2007-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

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• Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Self-reported anxiety symptomatology;Pain;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) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.; 🇸🇪 Uppsala, Sweden