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

Eli Lilly and Company560 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

560

Conditions

Anxiety Disorder

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). 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in the judgement of the investigator would interfere with compliance with study protocol * Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine * History of alcohol or any psychoactive substance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

Locations (22)

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

Secondary Outcomes

Self-reported anxiety symptomatology

Quality of Life

Clinical Global Improvement

HAMA factor scores

Data from ClinicalTrials.gov

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Buenos Aires, Argentina

Córdoba, Argentina

Rosario, Argentina

Everton Park, Queensland, Australia

Spring Hill, Queensland, Australia

Toowoomba, Queensland, Australia

Armadale, Victoria, Australia

Liège, Belgium

Tielt, Belgium

Kelowna, British Columbia, Canada

...and 12 more locations