Treatment Outcome of Vascular Depression
2 other identifiers
observational
208
1 country
2
Brief Summary
This 12-week study will evaluate the effectiveness of sertraline (Zoloft®) for treatment of depression associated with small vascular lesions in the brain (vascular depression).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2001
Longer than P75 for all trials
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
April 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 9, 2002
CompletedFirst Posted
Study publicly available on registry
September 11, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedOctober 31, 2017
October 1, 2017
5 years
September 9, 2002
October 27, 2017
Conditions
Study Arms (1)
1
Interventions
Eligibility Criteria
Adults 60+ with major depression.
You may qualify if:
- Ages 60+
- DSM-IV criteria for MDD
- Hamilton Depression Rating Scale score \>18
- No MRI contraindications, e.g. foreign metallic implants, pacemaker
- Medication free of any psychotropic drug except as otherwise noted for set washout period (see D.2.1)
- Mini Mental Status Exam score \<21
- No unstable medical disorders (requiring immediate medical attention)
- Ability to give informed consent
- English speaking
You may not qualify if:
- Age \<60
- Does not meet DSM-IV criteria for MDD
- Hamilton Depression Rating Scale score \<18
- MRI contraindications e.g. foreign metallic implants, pacemaker
- Psychotropic drug use other than zolpidem and lorazepam, prn within 2 weeks of entry
- Mini Mental Status Exam score \>21, or known primary neurological disorders including Dementia of the Alzheimer type, Parkinson's Disease, multiple sclerosis, seizure disorder.
- Unstable medical disorders, uncorrected hypothyroidism, or any condition that in the investigators opinion makes the patients unsuitable for a trial
- Cannot give informed consent
- Does not speak English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- National Institute of Mental Health (NIMH)collaborator
- Duke Universitycollaborator
Study Sites (2)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Related Publications (7)
Sheline YI, Black KJ, Lin DY, Christensen GE, Gado MH, Brunsden BS, Vannier MW. Stereological MRI volumetry of the frontal lobe. Psychiatry Res. 1996 Oct 7;67(3):203-14. doi: 10.1016/0925-4927(96)02831-4.
PMID: 8912959BACKGROUNDSheline Y, Loenze E, Cross D, et al., (1996) Quantifying white matter lesions in elderly women with depression. Presented at the Annual Meeting of the American College of Neuropsychopharmacology, San Juan, Puerto Rico.
BACKGROUNDSheline YI, Freedland KE, Carney RM. How safe are serotonin reuptake inhibitors for depression in patients with coronary heart disease? Am J Med. 1997 Jan;102(1):54-9. doi: 10.1016/s0002-9343(96)00374-9.
PMID: 9209201BACKGROUNDSheline Y.I. Neuroanatomical changes associated with unipolar major depression. The Neuroscientist 4:331-334, 1998
BACKGROUNDSheline YI, Price JL, Vaishnavi SN, Mintun MA, Barch DM, Epstein AA, Wilkins CH, Snyder AZ, Couture L, Schechtman K, McKinstry RC. Regional white matter hyperintensity burden in automated segmentation distinguishes late-life depressed subjects from comparison subjects matched for vascular risk factors. Am J Psychiatry. 2008 Apr;165(4):524-32. doi: 10.1176/appi.ajp.2007.07010175. Epub 2008 Feb 15.
PMID: 18281408RESULTSheline YI, Barch DM, Garcia K, Gersing K, Pieper C, Welsh-Bohmer K, Steffens DC, Doraiswamy PM. Cognitive function in late life depression: relationships to depression severity, cerebrovascular risk factors and processing speed. Biol Psychiatry. 2006 Jul 1;60(1):58-65. doi: 10.1016/j.biopsych.2005.09.019. Epub 2006 Jan 18.
PMID: 16414031RESULTSheline YI, Pieper CF, Barch DM, Welsh-Bohmer K, McKinstry RC, MacFall JR, D'Angelo G, Garcia KS, Gersing K, Wilkins C, Taylor W, Steffens DC, Krishnan RR, Doraiswamy PM. Support for the vascular depression hypothesis in late-life depression: results of a 2-site, prospective, antidepressant treatment trial. Arch Gen Psychiatry. 2010 Mar;67(3):277-85. doi: 10.1001/archgenpsychiatry.2009.204.
PMID: 20194828DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yvette I. Sheline, M.D.
Washington University Psychiatrist
- PRINCIPAL INVESTIGATOR
Murali Doraiswamy, M.D.
Duke University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Penn Faculty - McLure Professor
Study Record Dates
First Submitted
September 9, 2002
First Posted
September 11, 2002
Study Start
April 1, 2001
Primary Completion
April 1, 2006
Study Completion
April 1, 2006
Last Updated
October 31, 2017
Record last verified: 2017-10