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

Eli Lilly and Company480 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

480

Conditions

Anxiety Disorders

Interventions

DuloxetineDRUG

venlafaxineDRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (19)

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.

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Birmingham, Alabama, United States

La Mesa, California, United States

Denver, Colorado, United States

Washington D.C., District of Columbia, United States

Coral Springs, Florida, United States

Jacksonville, Florida, United States

Maitland, Florida, United States

Libertyville, Illinois, United States

Oakbrook Terrace, Illinois, United States

Florence, Kentucky, United States

...and 9 more locations