Duloxetine Compared With Placebo in Patients With Generalized Anxiety Disorder

This study has been completed.

Sponsor:

Collaborator:

Boehringer Ingelheim Pharmaceuticals

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00122824

First received: July 20, 2005

Last updated: November 5, 2007

Last verified: November 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

July 20, 2005

Last Updated Date

November 5, 2007

Start Date ^ICMJE

June 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

To assess duloxetine 120 mg once daily is superior to placebo in the treatment of GAD, defined as statistically greater reduction on the mean change anxiety symptoms as measured by the HAMA total score.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00122824 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Duloxetine Compared With Placebo in Patients With Generalized Anxiety Disorder

Official Title ^ICMJE

Duloxetine Hydrochloride 60 mg or 120 mg Once Daily Compared With Placebo in Patients With Generalized Anxiety Disorder.

Brief Summary

This is a clinical trial assessing duloxetine compared with placebo in patients who have generalized anxiety disorder.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Anxiety Disorders

Intervention ^ICMJE

Drug: duloxetine hydrochloride
Drug: placebo

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

480

Completion Date

September 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male and female outpatients at least 18 years of age

Exclusion Criteria:

Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine
Patient diagnosed with major depressive disorder within the past 6 months
Patient diagnosed with panic disorder, post-traumatic stress disorder, or an eating disorder within the past year
History of alcohol or any psychoactive substance abuse or dependence within the past 6 months

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Finland, France, Germany, South Africa, Spain, Sweden

Administrative Information

NCT Number ^ICMJE

NCT00122824

Other Study ID Numbers ^ICMJE

5075, F1J-MC-HMBR

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Investigators ^ICMJE

Study Director:

Call 1-877-285-4559 or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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