Subject Information and Consent Form F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain

Completed · Phase 3

Conditions studied: Depression, Pain

In brief

The purposes of this study are to determine whether an investigational drug can help patients suffering from major depression with pain symptoms, and gather data on the safety of the investigational drug including any side effects that might be associated with it.

Key facts

Study ID

NCT00036335

Run by

Eli Lilly and Company

People needed

286

Starts

2002-03-01

Expected to finish

2003-01-01

Last updated by the study team

2006-07-19

Who can join

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

You may qualify if…

• You must be suffering from symptoms of depression for at least the past 2 weeks (sadness, loss of interest in daily activities, feelings of hopelessness or guilt, sleeplessness or lack of energy)
• You must have pain symptoms with no known cause, such as unexplainable, head, chest, or back pain, overall aches and pains, or other unexplainable pains.
• You need to be available to visit a doctor's office about once a week for 10 weeks.

You may not qualify if…

• You are a woman and are pregnant or breastfeeding.
• You have a current or previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder.
• You have had a primary diagnosis of an anxiety disorder within the past 6 months.
• You have a history of alcohol or drug dependence or abuse within the past 6 months.
• You have a serious medical illness.

Where it is running

• Study site — Peoria, Arizona, United States
• Study site — Burbank, California, United States
• Study site — Fresno, California, United States
• Study site — St. Petersburg, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Oakbrook Terrace, Illinois, United States
• Study site — Springfield, Illinois, United States
• Study site — Glen Burnie, Maryland, United States
• Study site — Farmington Hills, Michigan, United States
• Study site — Nashua, New Hampshire, United States
• Study site — Clementon, New Jersey, United States
• Study site — Moorestown, New Jersey, United States
• Study site — Albany, New York, United States
• Study site — Olean, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Toledo, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Austin, Texas, United States
• Study site — Lake Jackson, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Woodstock, Vermont, United States
• Study site — Richmond, Virginia, United States
• Study site — Seattle, Washington, United States
• Study site — Brown Deer, Wisconsin, United States

Full record on ClinicalTrials.gov

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