Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression
2 other identifiers
interventional
N/A
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2002
Shorter than P25 for phase_3 major-depressive-disorder
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2002
CompletedFirst Posted
Study publicly available on registry
August 5, 2002
CompletedStudy Start
First participant enrolled
December 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2003
CompletedJuly 19, 2006
July 1, 2006
July 31, 2002
July 18, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Unknown Facility
Carlsbad, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Stanford, California, United States
Unknown Facility
Cromwell, Connecticut, United States
Unknown Facility
Coral Springs, Florida, United States
Unknown Facility
Gainesville, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Bangor, Maine, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Charlottesville, Virginia, United States
Unknown Facility
Falls Church, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
West Allis, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 31, 2002
First Posted
August 5, 2002
Study Start
December 1, 2002
Study Completion
December 1, 2003
Last Updated
July 19, 2006
Record last verified: 2006-07