A Comparison of Duloxetine Hydrochloride, Marketed Comparator, and Placebo in the Treatment of Generalized Anxiety Disorder

Phase 3

Completed

• Conditions: Anxiety Disorder

• Registration Number: NCT00122837
• Lead Sponsor: Eli Lilly and Company

Brief Summary

This is a clinical trial assessing duloxetine and comparator to placebo in patients who have generalized anxiety disorder.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-07-20
• Study First Submitted QC: 2005-07-20
• Study First Posted: 2005-07-22
• Study Completion: 2007-01
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-17
• Last Update Posted: 2007-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

• Male and female outpatients at least 18 years of age, presenting with generalized anxiety disorder (GAD).

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Exclusion Criteria

• Any current and primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I diagnosis other than GAD. Patients diagnosed with major depressive disorder within the past 6 months -or- patients diagnosed with panic disorder, post-traumatic stress disorder, or an eating disorder within the past year -or- obsessive-compulsive disorder, bipolar affective disorder, psychosis factitious disorder, or somatoform disorders during their lifetime
• The presence of an Axis II disorder or history of antisocial behavior, which in the judgement of the investigator would interfere with compliance with study protocol
• Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine
• History of alcohol or any psychoactive substance abuse or dependence (as defined in the DSM-IV-TR) within the past 6 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assess whether duloxetine hydrochloride 60 to 120 mg QD is superior to placebo in the treatment of GAD, 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) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test; 🇬🇧 Glasgow, Scotland, United Kingdom