Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression

NCT ID: NCT00042562

Last Updated: 2006-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2003-12-31

Brief Summary

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The purposes of this study are to determine:

The safety of duloxetine and any side effects that might be associated with it.

Whether duloxetine can help patients with major depression.

The safety associated with switching from a medication you may be taking for depression to taking duloxetine.

It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed.

Detailed Description

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Conditions

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Major Depressive Disorder

Keywords

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Depressed blues sadness feelings of guilt hopelessness lack of energy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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duloxetine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* You must be at least 18 years old.
* You must have been diagnosed with major depressive disorder.
* You must be able to visit the doctor's office once a week to once every 2 weeks for a total of 14 weeks

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 had a primary diagnosis of an anxiety disorder within the past 6 months.
* You have a history of alcohol or drug dependence or abuse within the past 6 months.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Locations

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Carlsbad, California, United States

Site Status

Los Angeles, California, United States

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Stanford, California, United States

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Cromwell, Connecticut, United States

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Coral Springs, Florida, United States

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Gainesville, Florida, United States

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Miami, Florida, United States

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Atlanta, Georgia, United States

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Bangor, Maine, United States

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Boston, Massachusetts, United States

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New York, New York, United States

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Rochester, New York, United States

Site Status

Cincinnati, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Charlottesville, Virginia, United States

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Falls Church, Virginia, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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West Allis, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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F1J-US-HMBZ

Identifier Type: -

Identifier Source: secondary_id

6476

Identifier Type: -

Identifier Source: org_study_id