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Treatment Outcome of Vascular Depression

This study has been completed.
National Institute of Mental Health (NIMH)
Duke University
Information provided by:
University of Pennsylvania Identifier:
First received: September 9, 2002
Last updated: August 29, 2016
Last verified: August 2016
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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Treatment Outcome of Vascular Depression

Resource links provided by NLM:

Further study details as provided by University of Pennsylvania:

Enrollment: 208
Study Start Date: April 2001
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Drug: Sertraline
50 - 200mg, once per day for 12 weeks.
Other Name: Zoloft

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.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

  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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00045773

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
University of Pennsylvania
National Institute of Mental Health (NIMH)
Duke University
Principal Investigator: Yvette I. Sheline, M.D. Washington University Psychiatrist
Principal Investigator: Murali Doraiswamy, M.D. Duke University
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yvette I. Sheline, MD, Washington University Identifier: NCT00045773     History of Changes
Other Study ID Numbers: R01MH060697 ( U.S. NIH Grant/Contract )
Study First Received: September 9, 2002
Last Updated: August 29, 2016

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs processed this record on September 21, 2017