Effect of Brain Lesion Severity on Treatment Response in Late-Life Depression
Treatment Outcomes of Vascular Depression
3 other identifiers
interventional
131
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started Aug 2001
Longer than P75 for not_applicable depression
2 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
Study Start
First participant enrolled
August 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 16, 2006
CompletedFirst Posted
Study publicly available on registry
June 20, 2006
CompletedAugust 9, 2013
February 1, 2008
4.6 years
June 16, 2006
August 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measured at Week 12: Montgomery-Asberg Depression Scale (MADRS)
Secondary Outcomes (4)
Measured at Week 12: Hamilton Depression Rating Scale (Ham-D)
Clinical Global Impression (CGI)
Quality of Life Assessment
Disability Assessment
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (2)
Washington University in St. Louis
St Louis, Missouri, 63130, United States
Duke University Medical Center
Durham, North Carolina, 27706, United States
Related Publications (1)
Taylor WD, Kuchibhatla M, Payne ME, Macfall JR, Sheline YI, Krishnan KR, Doraiswamy PM. Frontal white matter anisotropy and antidepressant remission in late-life depression. PLoS One. 2008 Sep 24;3(9):e3267. doi: 10.1371/journal.pone.0003267.
PMID: 18813343DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
P. Murali Doraiswamy, MD
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2006
First Posted
June 20, 2006
Study Start
August 1, 2001
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
August 9, 2013
Record last verified: 2008-02