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

Depression Clinical Trial

Official title:

Duloxetine Versus Escitalopram and Placebo in the Treatment of Patients With Major Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00073411
• Other study ID #: 7978
• Secondary ID: F1J-US-HMCR
• Status: Completed
• Phase: Phase 3
• First received: November 20, 2003
• Last updated: July 30, 2007
• Start date: November 2003
• Est. completion date: May 2005

Study information

• Verified date: July 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 675
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• duloxetine

• escitalopram

• placebo

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the onset of antidepressant efficacy for duloxetine 60 mg once-daily compared with escitalopram 10 mg once-daily.
Secondary	To compare the efficacy of duloxetine 60 mg once-daily versus escitalopram 10 mg once-daily and placebo during acute therapy
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	To evaluate safety and tolerability of duloxetine 60 mg once-daily vs. escitalopram 10 mg once-daily and placebo during acute therapy
Secondary	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
Secondary	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)
Secondary	To compare efficacy of duloxetine versus escitalopram in the placebo non-responders who enter the rescue phase

External Links

•   Lilly Clinical Trial Registry