Major Depressive Disorder Clinical Trial
Official title:
Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression
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:
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | December 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
United States,
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