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| Sponsored by: |
National Institute of Mental Health (NIMH) |
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00045773 |
Purpose
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).
| Condition | Intervention |
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Depressive Disorder Depression |
Drug: Sertraline (Zoloft) Procedure: MRI Scan Procedure: Cognitive Testing Procedure: EKG |
| MedlinePlus related topics: | Depression |
| ChemIDplus related topics: | Sertraline hydrochloride Sertraline |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Treatment Outcome of Vascular Depression |
| Estimated Enrollment: | 320 |
| Study Start Date: | April 2001 |
| Estimated Study Completion Date: | March 2006 |
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
| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| United States, Missouri | |||||
| Washington University School of Medicine | |||||
| St. Louis, Missouri, United States, 63110 | |||||
| United States, North Carolina | |||||
| Duke University Medical Center | |||||
| Durham, North Carolina, United States, 27710 | |||||
| Principal Investigator: | Yvette I. Sheline, M.D. | Washington University Psychiatrist |
More Information
Volunteer for Health with Washington University School of Medicine
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Washington University School of Medicine Psychiatry Department
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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.
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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.
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| 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. |
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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.
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| Study ID Numbers: | R01 MH60697, DATR A4-GPX |
| First Received: | September 9, 2002 |
| Last Updated: | July 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00045773 |
| Health Authority: | United States: Federal Government |
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