Subject Information and Consent Form F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain
NCT ID: NCT00036335
Last Updated: 2006-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
286 participants
INTERVENTIONAL
2002-03-31
2003-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Duloxetine Hydrochloride
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Locations
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Peoria, Arizona, United States
Burbank, California, United States
Fresno, California, United States
St. Petersburg, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Oakbrook Terrace, Illinois, United States
Springfield, Illinois, United States
Glen Burnie, Maryland, United States
Farmington Hills, Michigan, United States
Nashua, New Hampshire, United States
Clementon, New Jersey, United States
Moorestown, New Jersey, United States
Albany, New York, United States
Olean, New York, United States
Cincinnati, Ohio, United States
Toledo, Ohio, United States
Philadelphia, Pennsylvania, United States
Austin, Texas, United States
Lake Jackson, Texas, United States
San Antonio, Texas, United States
Woodstock, Vermont, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Brown Deer, Wisconsin, United States
Countries
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References
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Harada E, Kato M, Fujikoshi S, Wohlreich MM, Berggren L, Tokuoka H. Changes in energy during treatment of depression: an analysis of duloxetine in double-blind placebo-controlled trials. Int J Clin Pract. 2015 Oct;69(10):1139-48. doi: 10.1111/ijcp.12658. Epub 2015 May 16.
Dodd S, Berk M, Kelin K, Zhang Q, Eriksson E, Deberdt W, Craig Nelson J. Application of the Gradient Boosted method in randomised clinical trials: Participant variables that contribute to depression treatment efficacy of duloxetine, SSRIs or placebo. J Affect Disord. 2014 Oct;168:284-93. doi: 10.1016/j.jad.2014.05.014. Epub 2014 Jun 4.
Other Identifiers
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F1J-US-HMCB
Identifier Type: -
Identifier Source: secondary_id
6353
Identifier Type: -
Identifier Source: org_study_id