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

A Comparison of Duloxetine Hydrochloride, Venlafaxine Extended Release, and Placebo in the Treatment of Generalized Anxiety Disorder

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00122837

Enrollment

560

Registered

2005-07-22

Start date

2005-04-30

Completion date

2007-01-31

Last updated

2007-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorder

Brief summary

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

Interventions

DRUGDuloxetine

DRUGvenlafaxine

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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the judgement of the investigator would interfere with compliance with study protocol * Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine * History of alcohol or any psychoactive substance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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Self-reported anxiety symptomatology	—
Quality of Life	—
Clinical Global Improvement	—
HAMA factor scores	—

Countries

Argentina, Australia, Belgium, Canada, Mexico, Russia, Taiwan, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026