A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression
NCT ID: NCT00666757
Last Updated: 2010-06-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
750 participants
INTERVENTIONAL
2008-05-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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duloxetine
study drug
duloxetine
30-120 milligrams (mgs) orally daily for 12 weeks
citalopram
citalopram
20-40 mgs orally daily for 12 weeks
fluoxetine
fluoxetine
20-80 mgs orally daily for 12 weeks
paroxetine
paroxetine
20-50 mgs orally daily for 12 weeks
sertraline
sertraline
50-200 mgs orally daily for 12 weeks
Interventions
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duloxetine
30-120 milligrams (mgs) orally daily for 12 weeks
fluoxetine
20-80 mgs orally daily for 12 weeks
citalopram
20-40 mgs orally daily for 12 weeks
paroxetine
20-50 mgs orally daily for 12 weeks
sertraline
50-200 mgs orally daily for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have major depression and are currently in a severe depressive episode
* Have a degree of understanding such that patient can communicate with the investigator and study staff
* All females must test negative for pregnancy
* Females of childbearing potential must use reliable method of birth control during the study and for 1 month after taking the last dose of study drug
Exclusion Criteria
* Have a history of bipolar disorder, a psychotic disorder (such as schizophrenia), a cognitive disorder (such as moderate or severe dementia), or obsessive-compulsive disorder (OCD)
* Are at significant risk for suicide
* Have not responded to 2 or more adequate trials of antidepressant medications during the current depressive episode
* Have a serious, unstable medical condition
* Have a current or recent history of substance abuse or dependence
* Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (rTMS), or vagus nerve stimulation (VNS) in the past year
* Have started psychotherapy within 6 weeks prior to study entry
* Have a serious medical illness or clinically significant laboratory abnormality that is not stabilized or is anticipated, in the judgment of the investigator, to require hospitalization or use of an excluded medication during the course of the study
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Eli Lilly
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Carson, California, United States
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Irvine, California, United States
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San Diego, California, United States
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Sherman Oaks, California, United States
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Torrance, California, United States
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Pueblo, Colorado, United States
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Clearwater, Florida, United States
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Coral Springs, Florida, United States
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Deerfield Beach, Florida, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Hialeah, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, United States
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Joliet, Illinois, United States
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Oak Brook, Illinois, United States
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Park Ridge, Illinois, United States
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Greenwood, Indiana, United States
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Terre Haute, Indiana, United States
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Prairie Village, Kansas, United States
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Wichita, Kansas, United States
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Gaithersburg, Maryland, United States
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Glen Burnie, Maryland, United States
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Rockville, Maryland, United States
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Fall River, Massachusetts, United States
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St Louis, Missouri, United States
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Clementon, New Jersey, United States
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Princeton, New Jersey, United States
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Brooklyn, New York, United States
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Fresh Meadows, New York, United States
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Mount Kisco, New York, United States
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Rochester, New York, United States
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Staten Island, New York, United States
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Concord, North Carolina, United States
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Durham, North Carolina, United States
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Beachwood, Ohio, United States
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Dayton, Ohio, United States
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Kettering, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Eugene, Oregon, United States
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Havertown, Pennsylvania, United States
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Media, Pennsylvania, United States
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Newtown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Lincoln, Rhode Island, United States
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Columbia, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Friendswood, Texas, United States
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Houston, Texas, United States
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Lake Jackson, Texas, United States
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San Antonio, Texas, United States
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Wichita Falls, Texas, United States
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Woodstock, Vermont, United States
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Charlottesville, Virginia, United States
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Herndon, Virginia, United States
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Bellevue, Washington, United States
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Brown Deer, Wisconsin, United States
Countries
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References
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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.
Martinez JM, Katon W, Greist JH, Kroenke K, Thase ME, Meyers AL, Edwards SE, Marangell LB, Shoemaker S, Swindle R. A pragmatic 12-week, randomized trial of duloxetine versus generic selective serotonin-reuptake inhibitors in the treatment of adult outpatients in a moderate-to-severe depressive episode. Int Clin Psychopharmacol. 2012 Jan;27(1):17-26. doi: 10.1097/YIC.0b013e32834ce11b.
Other Identifiers
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F1J-US-HMFT
Identifier Type: OTHER
Identifier Source: secondary_id
11715
Identifier Type: -
Identifier Source: org_study_id
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