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CompletedNCT00045773Updated Oct 31, 2017

Treatment Outcome of Vascular Depression

An observational study in Depressive Disorder and Depression, sponsored by University of Pennsylvania. Completed at 2 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2017-10-31.

Sponsored by University of Pennsylvania · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
208
Ages
60 Years and older
Sex
All
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Study 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).

Read the detailed description

Major late life depression (LLD) is an important health problem with a large and growing number of affected individuals. A significant subset of patients with LLD, particularly those with vascular depression, have abnormalities in certain parts of the brain that are evident on MRI scans and may be associated with poor acute and long-term response to antidepressant treatment. Studies have also indicated that LLD patients frequently have frontal lobe dysfunction. A longitudinal study with the antidepressant nortriptyline has demonstrated that frontal lobe dysfunction is associated with poor acute response and a greater risk for recurrence of LLD. However, it is not known if this finding applies to other antidepressants. This study will be the first clinical trial to simultaneously test the effects of specific brain and psychological factors on course of response, remission rate, and other measures of health outcomes in people with LLD.

Participants are treated with sertraline for 12 weeks. During this period, participants undergo cognitive testing, MRI, electrocardiogram (EKG), and laboratory tests. Study visits occur every 2 weeks.

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Conditions studied

  • Depressive Disorder
  • Depression
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In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 208 is above the median of 160 across 1,084 observational studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults 60+ with major depression.

Inclusion criteria

  1. Ages 60+
  2. DSM-IV criteria for MDD
  3. Hamilton Depression Rating Scale score >18
  4. No MRI contraindications, e.g. foreign metallic implants, pacemaker
  5. Medication free of any psychotropic drug except as otherwise noted for set washout period (see D.2.1)
  6. Mini Mental Status Exam score \<21
  7. No unstable medical disorders (requiring immediate medical attention)
  8. Ability to give informed consent
  9. English speaking

Exclusion criteria

Exclusion Criteria:

  1. Age \<60
  2. Does not meet DSM-IV criteria for MDD
  3. Hamilton Depression Rating Scale score \<18
  4. MRI contraindications e.g. foreign metallic implants, pacemaker
  5. Psychotropic drug use other than zolpidem and lorazepam, prn within 2 weeks of entry
  6. Mini Mental Status Exam score >21, or known primary neurological disorders including Dementia of the Alzheimer type, Parkinson's Disease, multiple sclerosis, seizure disorder.
  7. Unstable medical disorders, uncorrected hypothyroidism, or any condition that in the investigators opinion makes the patients unsuitable for a trial
  8. Cannot give informed consent
  9. Does not speak English
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
208 participants (actual)

Groups and cohorts

  • 1

    Drug: Sertraline

Interventions

  • DrugSertraline

    50 - 200mg, once per day for 12 weeks.

    Also known as: Zoloft

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Study locations

2 sites
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
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References and documents

Publications

  • 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. PubMed 8912959 ↗
  • Sheline 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.
  • Sheline 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. PubMed 9209201 ↗
  • Sheline Y.I. Neuroanatomical changes associated with unipolar major depression. The Neuroscientist 4:331-334, 1998
  • Sheline 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. PubMed 18281408 ↗
  • Sheline 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. PubMed 16414031 ↗
  • Sheline 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. Erratum In: Arch Gen Psychiatry. 2010 Oct;67(10):1043. Welsh-Boehmer, Kathleen [corrected to Welsh-Bohmer, Kathleen]. PubMed 20194828 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00045773
Lead sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH), Duke University
Responsible party
Yvette Sheline (Penn Faculty - McLure Professor, University of Pennsylvania) — Principal investigator
First posted
Sep 11, 2002
Start date
Apr 2001
Primary completion
Apr 2006
Completion
Apr 2006
Last update
Oct 31, 2017

Study contacts

Yvette I. Sheline, M.D.
principal investigator · Washington University Psychiatrist
Murali Doraiswamy, M.D.
principal investigator · Duke University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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