Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in 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. 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. Duloxetine might not have any good effects for you.

Key facts

Study ID

NCT00042575

Run by

Eli Lilly and Company

People needed

120

Starts

2002-06-01

Expected to finish

2002-08-01

Last updated by the study team

2006-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• You must be at least 18 years old.
• You must be 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 8 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 a history of alcohol or drug dependence or abuse within the past 6 months.
• You are allergic to the study drug or you have experienced allergic reactions when taking several medications at once.
• You have a serious medical illness.

Where it is running

• Study site — Trumbull, Connecticut, United States
• Study site — Lafayette, Indiana, United States
• Study site — Gaithersburg, Maryland, United States
• Study site — Belmont, Massachusetts, United States
• Study site — Omaha, Nebraska, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Staten Island, New York, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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