Treatment of Vascular Depression
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on March 24, 2008 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depressive Disorder; Depression
Intervention: Sertraline (Zoloft) (Drug); MRI Scan (Procedure); Cognitive Testing (Procedure); EKG (Procedure)
Phase: N/A
Status: Active, not recruiting
Sponsored by: National Institute of Mental Health (NIMH) Official(s) and/or principal investigator(s): Yvette I. Sheline, M.D., Principal Investigator, Affiliation: Washington University Psychiatrist
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).
Clinical Details
Official title: Treatment Outcome of Vascular Depression
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
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.
Eligibility
Minimum age: 60 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of unipolar major depressive disorder based on a clinical interview by a
psychiatrist and a SCID interview
- English speaking
- Able to follow study procedures
Locations and Contacts
Washington University School of Medicine, St. Louis, Missouri 63110, United States
Duke University Medical Center, Durham, North Carolina 27710, United States
Additional Information
Volunteer for Health with Washington University School of Medicine Washington University School of Medicine Psychiatry Department
Related publications: Krishnan KR, Goli V, Ellinwood EH, France RD, Blazer DG, Nemeroff CB. Leukoencephalopathy in patients diagnosed as major depressive. Biol Psychiatry. 1988 Mar 1;23(5):519-22. No abstract available. 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. 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. Review.
Starting date: April 2001
Ending date: March 2006
Last updated: August 4, 2006
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