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

Lilly

Status and phase

Completed

Phase 3

Conditions

Anxiety Disorder

Treatments

Drug: placebo

Drug: venlafaxine

Drug: Duloxetine

Study type

Interventional

Funder types

Industry

Identifiers

F1J-MC-HMDW

7106

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine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