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Duloxetine Compared to Escitalopram and Placebo in the Treatment of Patients With Depression
This study has been completed.
Study NCT00073411   Information provided by Eli Lilly and Company
First Received: November 20, 2003   Last Updated: July 30, 2007   History of Changes

November 20, 2003
July 30, 2007
November 2003
 
To compare the onset of antidepressant efficacy for duloxetine 60 mg once-daily compared with escitalopram 10 mg once-daily.
Same as current
Complete list of historical versions of study NCT00073411 on ClinicalTrials.gov Archive Site
  • To compare the efficacy of duloxetine 60 mg once-daily versus escitalopram 10 mg once-daily and placebo during acute therapy
  • To compare the efficacy of duloxetine 60-120 mg once-daily versus escitalopram 10-20 mg once-daily and placebo for up to 8 months of therapy
  • To compare incidence of sexual dysfunction (defined by Changes in Sexual Functioning Questionnaire (CSFQ)), during acute therapy for patients treated with duloxetine 60 mg once-daily versus escitalopram 10 mg once-daily & placebo.
  • To compare sexual dysfunction during up to 8 months of treatment with duloxetine 60-120 mg once-daily versus escitalopram 10 to 20 mg once-daily and placebo
  • To compare impact of duloxetine 60 mg once-daily versus escitalopram 10 mg once-daily & placebo during acute therapy & during 8 months of therapy on quality of life, functional/health outcomes, & patient satisfaction with study drug
  • To compare impact of duloxetine 60-120 mg once-daily versus escitalopram 10 to 20 mg once-daily and placebo for up to 8 months of therapy on quality of life, functional/health outcomes, & patient satisfaction with study drug
  • To compare impact of duloxetine 60-120 mg once-daily versus escitalopram 10-20 mg once-daily and placebo during acute and extended therapy on resource utilization (% patients using more,less or equal number of health care providers and services)
  • To evaluate safety and tolerability of duloxetine 60 mg once-daily vs. escitalopram 10 mg once-daily and placebo during acute therapy
  • To evaluate the safety and tolerability of duloxetine 60-120 mg once-daily vs. escitalopram 10-20 mg once-daily and placebo for up to 8 months of therapy
  • To compare percentage of patients taking duloxetine 60 mg once-daily versus escitalopram 10 mg once-daily and placebo requiring a dose escalation due to less than satisfactory initial response (defined by IRB supplement or investigator request)
  • To compare efficacy of duloxetine versus escitalopram in the placebo non-responders who enter the rescue phase
Same as current
 
Duloxetine Compared to Escitalopram and Placebo in the Treatment of Patients With Depression
Duloxetine Versus Escitalopram and Placebo in the Treatment of Patients With Major Depression

The purposes of this study are to determine:

  • The safety of duloxetine and any side effects that might be associated with it.
  • How duloxetine compares to escitalopram and placebo (an inactive ingredient)

duloxetine 60mg - 120mg, escitalopram 10mg - 20mg, and placebo, 8-month,

Phase III
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Depression
  • Drug: duloxetine
  • Drug: escitalopram
  • Drug: placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
675
May 2005
 

Inclusion Criteria:

  • Must be at least 18 of age
  • 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 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 within the past 6 months
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00073411
 
7978, F1J-US-HMCR
Eli Lilly and Company
 
Study Director: 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) Eli Lilly and Company
Eli Lilly and Company
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP