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

This study has been completed.

Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00042562
  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 III

MedlinePlus related topics:   Depression   

Drug Information available for:   Duloxetine    Duloxetine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression

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
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

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

Locations
United States, California
      Los Angeles, California, United States
      Carlsbad, 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
      Rochester, New York, United States
      New York, 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
      Falls Church, Virginia, United States
      Richmond, Virginia, United States
      Charlottesville, 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


Study ID Numbers:   6476, F1J-US-HMBZ
First Received:   July 31, 2002
Last Updated:   July 18, 2006
ClinicalTrials.gov Identifier:   NCT00042562
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

Study placed in the following topic categories:
Dopamine
Depression
Fatigue
Mental Disorders
Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Serotonin
Duloxetine
Behavioral Symptoms

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 20, 2008

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