Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression

Completed · Phase 3

Conditions studied: Major Depressive Disorder

In brief

The purposes of this study are to determine: The safety of duloxetine and any side effects that might be associated with it. Whether duloxetine can help patients with major depression. The safety associated with switching from a medication you may be taking for depression to taking duloxetine. It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed.

Key facts

Study ID

NCT00042562

Run by

Eli Lilly and Company

Starts

2002-12-01

Expected to finish

2003-12-01

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 at least 18 years old.
• You must have been diagnosed with major depressive disorder.
• You must be able to visit the doctor's office once a week to once every 2 weeks for a total of 14 weeks

You may not qualify if…

• You are a woman and are pregnant or breastfeeding.
• You have a current or previous major psychiatric disorder other than depression, such as 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.

Where it is running

• Study site — Carlsbad, California, United States
• Study site — Los Angeles, California, United States
• Study site — Stanford, California, United States
• Study site — Cromwell, Connecticut, United States
• Study site — Coral Springs, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Bangor, Maine, United States
• Study site — Boston, Massachusetts, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Charlottesville, Virginia, United States
• Study site — Falls Church, Virginia, United States
• Study site — Richmond, Virginia, United States
• Study site — Seattle, Washington, United States
• Study site — West Allis, Wisconsin, United States

Full record on ClinicalTrials.gov

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