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 Disorders

Treatments: Drug: venlafaxine; Drug: placebo; Drug: Duloxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00122850

7107

F1J-MC-HMDU

Details and patient eligibility

About

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind