Duloxetine vs Placebo in the Treatment of General Anxiety

Completed · Phase 3 · Has a placebo group

Conditions studied: Anxiety

In brief

To see if duloxetine 60 to 120 mg once daily (QD) is better than placebo in the treatment of generalized anxiety disorder (GAD).

Key facts

Study ID: NCT00475969
Run by: Eli Lilly and Company
People needed: 327
Starts: 2004-08-01
Expected to finish: 2005-06-01
Last updated by the study team: 2007-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male and female outpatients at least 18 years of age presenting with generalized anxiety disorder (GAD) based on the disease diagnostic criteria The patient must suffer from GAD and not from an adjustment disorder or anxiety disorder not otherwise specified (NOS). Symptoms of GAD should not be situational in nature.
Females of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) who are not breastfeeding; test negative for pregnancy at the time of enrollment based on a urine 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.
Must have a Clinical Global Impressions of Severity (CGI-Severity) score of greater than or equal to 4 at Visit 1 and Visit 2.
At Visit 1, patient must have a Covi Anxiety Scale (CAS) score of greater than or equal to 9, no item in the Raskin Depression Scale (RDS) may be greater than 3, and the CAS must be greater than the RDS.
Must have a Hospital Anxiety and Depression Scale (HADS) anxiety subscale score of greater than or equal to 10 at Visit 1.

You may not qualify if…

Any current and primary DSM-IV Axis I diagnosis other than GAD.
Patients diagnosed with or who have a history of major depressive disorder (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.
The presence of an Axis II disorder or history of antisocial behavior, which, in the judgment of the investigator, would interfere with compliance with the study protocol.
Benzodiazepine use 14 days prior to Visit 2.
Patients judged clinically to be at serious suicidal risk, or patients who, in the opinion of the investigator, are poor medical or psychiatric risks for study completion.
Have received treatment within the last 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry.

Where it is running

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 - 5 hours, EST) or speak with your personal physician. — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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