Duloxetine Versus Venlafaxine Extended Release in the Treatment of Major Depressive Disorder

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 4

Interventional

Study Start: July 2003

See protocol details

Summary

Principal SponsorEli Lilly and Company

Last updated: January 14, 2026

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

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

How duloxetine compares to a medication currently available for the treatment of patients diagnosed with depression

Official TitleDuloxetine Versus Venlafaxine Extended Release in the Treatment of Major Depressive Disorder

NCT00071695

Principal SponsorEli Lilly and Company

Last updated: January 14, 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

320 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 years of age * Must be diagnosed with depression * Must sign informed consent * Women who can become pregnant must be using birth control Exclusion Criteria: * Previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder * History of substance abuse or dependence in the last year * Patients who are suicidal * Frequent or severe allergic reactions with multiple medications

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 - 5 PM Easter Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.La Rochelle, FranceSee the location

CompletedOne Study Center

Duloxetine Versus Venlafaxine Extended Release in the Treatment of Major Depressive Disorder

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

The linear measure of global benefit-risk assessment. Benefit defined as remission at endpoint (HAMD 17 total score less than or equal to 7), a virtually symptom-free state.

HAMD17 Response Rates defined as greater than or equal to 50% reduction in HAMD17 total score from baseline to endpoint.

HAMD17 Time-to-First Response defined as the visit where a sustained greater than or equal to 30% reduction in the Maier subscale of the HAMD17.

HAMD17 Remission Rates defined as HAMD17 total score of less than or equal to 7 at endpoint.

Hamilton Anxiety Rating Scale measures the presence and severity of anxiety.

Clinical Global Impressions of Severity scale to record severity of illness at the time of assessment.

Patient's Global Impressions of Improvement scale measures improvement of the patient's symptoms.

HAMD17 Subscales evaluate severity of psychic and somatic manifestations of anxiety as well as agitation and evaluate dysfunction in mood, work, and sexual activity, as well as overall motor retardation and evaluate initial, middle, and late insomnia.

Study Centers

This study has 1 location

Mental Disorders
+2