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

Eli Lilly and Company1 site in 1 country480 target enrollmentOctober 2004

ConditionsAnxiety Disorders

DrugsDuloxetine venlafaxine placebo

Overview

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

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will examine duloxetine compared with placebo and an active comparator in the treatment of generalized anxiety disorder.

Registry

clinicaltrials.gov

Start Date

October 2004

End Date

November 2005

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

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) 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.

Outcomes

Primary Outcomes

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.