Clinical Trial: Treatment of Vascular Depression

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

The purpose of this study is to determine the effectiveness of the antidepressant sertraline (Zoloft) in treating people with vascular depression. A second goal is to determine how well a Magnetic Resonance Imaging (MRI) scan and tests of concentration, thought, and memory can predict response to antidepressant medications. This study will also test the effects of frontal lobe dysfunction on treatment response.

Condition Treatment or Intervention
Depressive Disorder
Depression
 Drug: Sertraline (Zoloft)
 Procedure: MRI Scan
 Procedure: Cognitive Testing
 Procedure: EKG

MedlinePlus related topics:  Depression;   Mental Health

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Official Title: Treatment Outcome of Vascular Depression

Further Study Details: 

Expected Total Enrollment:  320

Study start: April 2001;  Expected completion: 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 above,  Genders Eligible for Study:  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

Location and Contact Information

Patty Flynn, RN, BSN      314-367-6737    flynnp@npg.wustl.edu

Missouri
      Washington University School of Medicine, St. Louis,  Missouri,  63110,  United States; Recruiting
Yvette Sheline
Yvette I. Sheline, M.D.,  Principal Investigator

North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States; Recruiting
Cammie Hellegers  919-681-3986    helle003@mc.duke.edu 
Murali Doraiswamy, M.D.,  Principal Investigator

Study chairs or principal investigators

Yvette I. Sheline, M.D.,  Principal Investigator,  Washington University Psychiatrist   

More Information

Volunteer for Health with Washington University School of Medicine

Washington University School of Medicine Psychiatry Department

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.

Study ID Numbers:  60697-01A2; MH 60697
Record last reviewed:  March 2005
Last Updated:  March 2, 2005
Record first received:  September 9, 2002
ClinicalTrials.gov Identifier:  NCT00045773
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005