Completed

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

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What is being tested

Data Collection

Who is being recruted

Mental Disorders
+2

+ Behavioral Symptoms

+ Depression

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: November 2003

See protocol details

Summary

Principal SponsorEli Lilly and Company

Last updated: January 18, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2003Actual date on which the first participant was enrolled.

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

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

NCT00073411

Principal SponsorEli Lilly and Company

Last updated: January 18, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

675 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sexBiological sex of participants that are eligible to enroll.

Over 18 YearsRange of ages for which participants are eligible to join.

Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental Disorders

Behavioral Symptoms

Depression

Depressive Disorder

Mood Disorders

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

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, United StatesSee the location

CompletedOne Study Center

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

Data Collection

Mental Disorders+2

+ Behavioral Symptoms

+ Depression

Treatment Study

Summary

Protocol

Randomized Allocation

Parallel Assignment

Double-Blind Study

Eligibility

Conditions

Criteria

Study Plan

Study Objectives

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

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

Study Centers

This study has 1 location

Mental Disorders
+2