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

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression

Intervention: duloxetine (Drug); escitalopram (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

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)

Clinical Details

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

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

Primary outcome: To compare the onset of antidepressant efficacy for duloxetine 60 mg once-daily compared with escitalopram 10 mg once-daily.

Secondary outcome:

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

Detailed description:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

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
Additional Information

Lilly Clinical Trial Registry

Starting date: November 2003
Last updated: July 30, 2007

Page last updated: August 20, 2015

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