Duloxetine Compared to Escitalopram and Placebo in the Treatment of Patients With Depression

Phase 3

Completed

• Conditions: Depression

• Registration Number: NCT00073411
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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)

Detailed Description

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

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2003-11-20
• Study First Submitted QC: 2003-11-20
• Study First Posted: 2003-11-21
• Study Completion: 2005-05
• Status Verified: 2007-07
• Last Update Submitted: 2007-07-30
• Last Update Posted: 2007-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 675

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To compare the onset of antidepressant efficacy for duloxetine 60 mg once-daily compared with escitalopram 10 mg once-daily.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

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