Duloxetine Compared With Placebo in Patients With Generalized Anxiety Disorder - Full Text View

Sponsors and Collaborators:	Eli Lilly and Company Boehringer Ingelheim Pharmaceuticals
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00122824

Purpose

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

Condition	Intervention	Phase
Anxiety Disorders	Drug: duloxetine hydrochloride Drug: placebo	Phase III

MedlinePlus related topics: Anxiety

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Duloxetine Hydrochloride 60 mg or 120 mg Once Daily Compared With Placebo in Patients With Generalized Anxiety Disorder.

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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

Estimated Enrollment:	480
Study Start Date:	June 2004
Study Completion Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122824

Locations

United States, Ohio
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Cincinnati, Ohio, United States, 45242
Finland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Oulu, Finland, 90100
France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Bourg-en-Bresse, France, 01000
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Berlin, Germany, 10629
South Africa
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Paarl, South Africa, 7646
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Barcelona, Spain, 08013
Sweden
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Uppsala, Sweden, 75324

Sponsors and Collaborators

Eli Lilly and Company

Boehringer Ingelheim Pharmaceuticals

Investigators

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

More Information

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Publications indexed to this study:

Sheehan DV, Meyers AL, Prakash A, Robinson MJ, Swindle RW, Russell JM, Mallinckrodt CH. The relationship between functional outcomes and the treatment of anxious and painful somatic symptoms in patients with generalized anxiety disorder. Curr Med Res Opin. 2008 Sep;24(9):2457-66. Epub 2008 Jul 24.

Allgulander C, Hartford J, Russell J, Ball S, Erickson J, Raskin J, Rynn M. Pharmacotherapy of generalized anxiety disorder: results of duloxetine treatment from a pooled analysis of three clinical trials. Curr Med Res Opin. 2007 Jun;23(6):1245-52. Epub 2007 Apr 25.

Endicott J, Russell JM, Raskin J, Detke MJ, Erickson J, Ball SG, Marciniak M, Swindle RW. Duloxetine treatment for role functioning improvement in generalized anxiety disorder: three independent studies. J Clin Psychiatry. 2007 Apr;68(4):518-24. Erratum in: J Clin Psychiatry. 2007 Apr;68(4):518. J Clin Psychiatry. 2007 May;68(5):806.

Study ID Numbers:	5075, F1J-MC-HMBR
Study First Received:	July 20, 2005
Last Updated:	November 5, 2007
ClinicalTrials.gov Identifier:	NCT00122824
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dopamine
Anxiety Disorders
Mental Disorders
Serotonin
Duloxetine

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs

Serotonin Uptake Inhibitors
Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009