Depression Clinical Trial
Official title:
Duloxetine Hydrochloride (LY248686) Protocol F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain
Verified date | July 2006 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 286 |
Est. completion date | January 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Eli Lilly and Company |
United States,
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