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

Purpose

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.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: duloxetine	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression

Resource links provided by NLM:

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:


Study Start Date:	December 2002
Estimated Study Completion Date:	December 2003

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042562

Locations


United States, California

Carlsbad, California, United States

Los Angeles, California, United States

Stanford, California, United States
United States, Connecticut

Cromwell, Connecticut, United States
United States, Florida

Coral Springs, Florida, United States

Gainesville, Florida, United States

Miami, Florida, United States
United States, Georgia

Atlanta, Georgia, United States
United States, Maine

Bangor, Maine, United States
United States, Massachusetts

Boston, Massachusetts, United States
United States, New York

New York, New York, United States

Rochester, New York, United States
United States, Ohio

Cincinnati, Ohio, United States
United States, Pennsylvania

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States
United States, Texas

Dallas, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States
United States, Virginia

Charlottesville, Virginia, United States

Falls Church, Virginia, United States

Richmond, Virginia, United States
United States, Washington

Seattle, Washington, United States
United States, Wisconsin

West Allis, Wisconsin, United States

Sponsors and Collaborators

Eli Lilly and Company

More Information


ClinicalTrials.gov Identifier:	NCT00042562 History of Changes
Other Study ID Numbers:	6476 F1J-US-HMBZ
Study First Received:	July 31, 2002
Last Updated:	July 18, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:


Depressed blues sadness	feelings of guilt hopelessness lack of energy

Additional relevant MeSH terms:


Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Duloxetine Hydrochloride Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators	Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Antidepressive Agents Psychotropic Drugs Dopamine Agents

ClinicalTrials.gov processed this record on September 27, 2016