ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Treatment of Vascular Depression

This study is ongoing, but not recruiting participants.

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
Depressive Disorder
Depression
Drug: Sertraline (Zoloft)
Procedure: MRI Scan
Procedure: Cognitive Testing
Procedure: EKG

MedlinePlus related topics:   Depression   

ChemIDplus related topics:   Sertraline hydrochloride    Sertraline   

U.S. FDA Resources

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 as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment:   320
Study Start Date:   April 2001
Estimated Study Completion Date:   March 2006

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
Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045773

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

Sponsors and Collaborators

Investigators
Principal Investigator:     Yvette I. Sheline, M.D.     Washington University Psychiatrist    
  More Information

Volunteer for Health with Washington University School of Medicine  This link exits the ClinicalTrials.gov site
 
Washington University School of Medicine Psychiatry Department  This link exits the ClinicalTrials.gov site
 

Publications:

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

Study placed in the following topic categories:
Depression
Mental Disorders
Mood Disorders
Sertraline
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 05, 2008




Links to all studies - primarily for crawlers