Duloxetine Compared With Placebo in Patients With Generalized Anxiety Disorder

Phase 3CompletedNCT00122824

Eli Lilly and Company480 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

480

Conditions

Anxiety Disorders

Interventions

duloxetine hydrochlorideDRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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Criteria: * Male and female outpatients at least 18 years of age Exclusion Criteria: * Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine * Patient diagnosed with major depressive disorder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

Locations (7)

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.

Cincinnati, Ohio, United States

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.

Secondary Outcomes

Self-reported anxiety symptomatology;Pain;Quality of Life;Clinical Global Improvement;HAMA factor scores

Data from ClinicalTrials.gov

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