A Comparison of Duloxetine Hydrochloride, Venlafaxine Extended Release, and Placebo in the Treatment of Generalized Anxiety Disorder

Eli Lilly and Company1 site in 1 country560 target enrollmentApril 2005

ConditionsAnxiety Disorder

DrugsDuloxetine venlafaxine placebo

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Anxiety Disorder
Sponsor: Eli Lilly and Company
Enrollment: 560
Locations: 1
Primary Endpoint: 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
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 and comparator to placebo in patients who have generalized anxiety disorder.

Registry

clinicaltrials.gov

Start Date

April 2005

End Date

January 2007

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, presenting with generalized anxiety disorder (GAD).

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•Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine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

Outcomes

Primary Outcomes

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