Duloxetine Compared to Escitalopram and Placebo in the Treatment of Patients With Depression
NCT ID: NCT00073411
Last Updated: 2007-07-31
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
675 participants
INTERVENTIONAL
2003-11-30
2005-05-31
Brief Summary
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* The safety of duloxetine and any side effects that might be associated with it.
* How duloxetine compares to escitalopram and placebo (an inactive ingredient)
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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duloxetine
escitalopram
placebo
Eligibility Criteria
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Inclusion Criteria
* Must meet the criteria for major depressive disorder
* You must be able to visit the doctor's office about once a week for 2 to 3 months. After that, you will need to visit the doctor's office once a month for about 6 months
* You must be able to take the study drug as prescribed (6 capsules per day taken once-daily)
Exclusion Criteria
* 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 within the past 6 months
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Cincinnati, Ohio, 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.
Gueorguieva R, Mallinckrodt C, Krystal JH. Trajectories of depression severity in clinical trials of duloxetine: insights into antidepressant and placebo responses. Arch Gen Psychiatry. 2011 Dec;68(12):1227-37. doi: 10.1001/archgenpsychiatry.2011.132.
Sheehan DV, Harnett-Sheehan K, Spann ME, Thompson HF, Prakash A. Assessing remission in major depressive disorder and generalized anxiety disorder clinical trials with the discan metric of the Sheehan disability scale. Int Clin Psychopharmacol. 2011 Mar;26(2):75-83. doi: 10.1097/YIC.0b013e328341bb5f.
Prakash A, Risser RC, Mallinckrodt CH. The impact of analytic method on interpretation of outcomes in longitudinal clinical trials. Int J Clin Pract. 2008 Aug;62(8):1147-58. doi: 10.1111/j.1742-1241.2008.01808.x. Epub 2008 Jun 28.
Pigott TA, Prakash A, Arnold LM, Aaronson ST, Mallinckrodt CH, Wohlreich MM. Duloxetine versus escitalopram and placebo: an 8-month, double-blind trial in patients with major depressive disorder. Curr Med Res Opin. 2007 Jun;23(6):1303-18. doi: 10.1185/030079907X188107. Epub 2007 Apr 27.
Nierenberg AA, Greist JH, Mallinckrodt CH, Prakash A, Sambunaris A, Tollefson GD, Wohlreich MM. Duloxetine versus escitalopram and placebo in the treatment of patients with major depressive disorder: onset of antidepressant action, a non-inferiority study. Curr Med Res Opin. 2007 Feb;23(2):401-16. doi: 10.1185/030079906X167453.
Other Identifiers
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F1J-US-HMCR
Identifier Type: -
Identifier Source: secondary_id
7978
Identifier Type: -
Identifier Source: org_study_id