A clinical trial assessing the time to relapse of anxiety symptoms among patients with Generalized Anxiety disorder who have responded to duloxetine therapy.

Condition	Intervention	Phase
Anxiety Disorders	Drug: Duloxetine Hydrochloride	Phase III

Further Study Details: 

Ages Eligible for Study:  19 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

* Male and female outpatients at least 18 years old presenting with generalized anxiety disorder (GAD)absent of major depressive disorder(MDD) in the absence of major depressive disorder based on the disease diagnostic criteria (Section 4.2.1). Patients must suffer from GAD and not from and adjustment disorder or anxiety disorder not otherwise specified (NOS). Symptoms of GAD should not be situational in nature.

* Female of childbearing potential (not surgically sterilized and between menarche and year post-menopause) who are not breast-feeding; test negative for pregnancy at the time of enrollment based on a serum pregnancy test; and agree to use a reliable method of birth control during the study and for 1 week following the last dose of study drug.

Exclusion Criteria:

* Any current and primary DSM-IV-TR Axis I diagnosis other than GAD. Patients diagnosed with or who have a history of MDD within the past 6 months OR patients diagnosed with or who have a history of panic disorder, post-traumatic stress disorder (PTSD), or an eating disorder within the past year OR patients who have been diagnosed with obsessive- compulsive disorder (OCD), bipolar affective disorder, psychosis, factitious disorder or somatoform disorders during their lifetime.

* Treatment with a monoamine oxidase inhibitor (MAOI) or fluoxetine within 30 days of Visit 2 or potential need to use an MAOI during the study or within 5 days of discontinuation of study drug

* History of alcohol or any psychoactive substance abuse of dependence(as defined in the DSM-IV-TR) within the past 6 months

* Serious Medical illness, including cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require hospitalization within 6 months, in the opinion of the investigator. Clinically significant laboratory abnormalities are those, that, in the judgement of the investigator, indicate a serious medical problem.

* Acute liver injury (such as hepatitis) or severe cirrhosis (Child- Pugh Class C)

Please refer to this study by ClinicalTrials.gov identifier  NCT00122863

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or      1-317-615-4559 

California
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Sherman Oaks,  California,  United States; Recruiting
Florida
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Coral Springs,  Florida,  United States; Recruiting
Georgia
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Atlanta,  Georgia,  United States; Recruiting
Kansas
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Prairie Village,  Kansas,  United States; Recruiting
Massachusetts
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Belmont,  Massachusetts,  United States; Recruiting
Missouri
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, St. Charles,  Missouri,  United States; Recruiting
New York
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, New York,  New York,  United States; Recruiting
North Carolina
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Chapel Hill,  North Carolina,  United States; Recruiting
Ohio
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Dayton,  Ohio,  United States; Recruiting
Pennsylvania
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST), or speak with your personal physician, Hershey,  Pennsylvania,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Allentown,  Pennsylvania,  United States; Recruiting
Rhode Island
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Lincoln,  Rhode Island,  United States; Recruiting
South Carolina
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Charleston,  South Carolina,  United States; Recruiting
Texas
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST), or speak with your personal physician, Wichita Falls,  Texas,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Lake Jackson,  Texas,  United States; Recruiting
Vermont
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Woodstock,  Vermont,  United States; Recruiting
Washington
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Bellevue,  Washington,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Seattle,  Washington,  United States; Recruiting
Wisconsin
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Madison,  Wisconsin,  United States; Recruiting
Austria
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Wien,  Austria; Recruiting
France
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Clermont-Ferrand,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Cherbourg,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Caen,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Mulhouse,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Orvault,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Bordeaux,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Rennes,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Arachon,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Metz,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Aix-en-Provence,  France; Recruiting
Germany
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Berlin,  Germany; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Gottingen,  Germany; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Dresden,  Germany; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Werneck,  Germany; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Munchen,  Germany; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Hamburg,  Germany; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Munster,  Germany; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Leipzig,  Germany; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Mannheim,  Germany; Recruiting
Netherlands
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Rotterdam,  Netherlands; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Nijverdal,  Netherlands; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Rijswijk,  Netherlands; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Roelofarendsveen,  Netherlands; Recruiting
Portugal
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Porto,  Portugal; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Lisboa,  Portugal; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Ceira,  Portugal; Recruiting
Puerto Rico
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Ponce,  Puerto Rico; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST) or speak with your personal physician, Hato Rey,  Puerto Rico; Recruiting

Study chairs or principal investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM – 5 PM Eastern time (UTC/GMT- 5 hours, EST),  Study Director,  Eli Lilly and Company   

Study ID Numbers:  7108
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00122863
Health Authority: United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2005-07-26