Trial record 1 of 1 for:
HMCB
Subject Information and Consent Form F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain
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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 |
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Recruitment Status :
Completed
First Posted : May 10, 2002
Last Update Posted : July 19, 2006
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Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
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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 |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Depression
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| 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
| 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):
| 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:
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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 |