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Subject Information and Consent Form F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00036335
Recruitment Status : Completed
First Posted : May 10, 2002
Last Update Posted : July 19, 2006
Sponsor:
Information provided by:
Eli Lilly and Company

Brief Summary:
The purposes of this study are to determine whether an investigational drug can help patients suffering from major depression with pain symptoms, and gather data on the safety of the investigational drug including any side effects that might be associated with it.

Condition or disease Intervention/treatment Phase
Depression Pain Drug: Duloxetine Hydrochloride Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Duloxetine Hydrochloride (LY248686) Protocol F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain
Study Start Date : March 2002
Study Completion Date : January 2003

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • You must be suffering from symptoms of depression for at least the past 2 weeks (sadness, loss of interest in daily activities, feelings of hopelessness or guilt, sleeplessness or lack of energy)
  • You must have pain symptoms with no known cause, such as unexplainable, head, chest, or back pain, overall aches and pains, or other unexplainable pains.
  • You need to be available to visit a doctor's office about once a week for 10 weeks.

Exclusion Criteria:

  • You are a woman and are pregnant or breastfeeding.
  • You have a current or previous diagnosis of 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.
  • You have a serious medical illness.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00036335


Locations
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United States, Arizona
Peoria, Arizona, United States
United States, California
Burbank, California, United States
Fresno, California, United States
United States, Florida
St. Petersburg, Florida, United States
West Palm Beach, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Oakbrook Terrace, Illinois, United States
Springfield, Illinois, United States
United States, Maryland
Glen Burnie, Maryland, United States
United States, Michigan
Farmington Hills, Michigan, United States
United States, New Hampshire
Nashua, New Hampshire, United States
United States, New Jersey
Clementon, New Jersey, United States
Moorestown, New Jersey, United States
United States, New York
Albany, New York, United States
Olean, New York, United States
United States, Ohio
Cincinnati, Ohio, United States
Toledo, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
Austin, Texas, United States
Lake Jackson, Texas, United States
San Antonio, Texas, United States
United States, Vermont
Woodstock, Vermont, United States
United States, Virginia
Richmond, Virginia, United States
United States, Washington
Seattle, Washington, United States
United States, Wisconsin
Brown Deer, Wisconsin, United States
Sponsors and Collaborators
Eli Lilly and Company

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00036335    
Other Study ID Numbers: 6353
F1J-US-HMCB
First Posted: May 10, 2002    Key Record Dates
Last Update Posted: July 19, 2006
Last Verified: July 2006
Keywords provided by Eli Lilly and Company:
depression
pain
blues
sadness
aches
Additional relevant MeSH terms:
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Depression
Depressive Disorder
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