Back to resultsOpen-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
duloxetine
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depressed, blues, sadness, feelings of guilt, hopelessness, lack of energy
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00042562
Brief Title
Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression
Official Title
Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depressed, blues, sadness, feelings of guilt, hopelessness, lack of energy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
duloxetine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Carlsbad
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Stanford
State/Province
California
Country
United States
City
Cromwell
State/Province
Connecticut
Country
United States
City
Coral Springs
State/Province
Florida
Country
United States
City
Gainesville
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Bangor
State/Province
Maine
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
New York
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Charlottesville
State/Province
Virginia
Country
United States
City
Falls Church
State/Province
Virginia
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
West Allis
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression
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