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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.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00042562
First received: July 31, 2002
Last updated: July 18, 2006
Last verified: July 2006
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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 Intervention Model: Single Group Assignment Masking: None (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:
Further study details as provided by Eli Lilly and Company:
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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 |
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 August 22, 2017