Status:
COMPLETED
Effect of Brain Lesion Severity on Treatment Response in Late-Life Depression
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Depression
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
This study will determine the relationship between brain lesion severity, treatment response, and frontal lobe brain function in people with late-life depression (LLD).
Detailed Description
Depression in older adults is a major public health problem and it often goes underdiagnosed and undertreated. A significant number of people with LLD, especially those with cerebrovascular risk facto...
Eligibility Criteria
Inclusion
- DSM-IV of major depressive disorder (MDD)
- Score of greater than 20 on the MADRS (score of greater than 17 for atypical depression)
- Score of greater than 20 on the Mini Mental State Examination (MMSE)
Exclusion
- Any condition that may make having an MRI medically inadvisable
- Any severe or unstable medical conditions
- Any known primary neurological disorders, including history of stroke
- Any other simultaneous Axis I disorder
- History of substance or alcohol abuse disorder within 6 months prior to study entry
- Currently at risk for suicide
- History of failed prior adequate trials of two antidepressants for the current depressive episode
- History of failed prior adequate trial of sertraline
- Current use of any other psychoactive medications (medication washout will be required)
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00339066
Start Date
August 1 2001
End Date
March 1 2006
Last Update
August 9 2013
Active Locations (2)
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1
Washington University in St. Louis
St Louis, Missouri, United States, 63130
2
Duke University Medical Center
Durham, North Carolina, United States, 27706