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Treatment Outcome of Vascular Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00045773
Recruitment Status : Completed
First Posted : September 11, 2002
Last Update Posted : October 31, 2017
National Institute of Mental Health (NIMH)
Duke University
Information provided by (Responsible Party):
Yvette Sheline, University of Pennsylvania

Brief 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).

Condition or disease Intervention/treatment
Depressive Disorder Depression Drug: Sertraline

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.

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Study Type : Observational
Actual Enrollment : 208 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Treatment Outcome of Vascular Depression
Study Start Date : April 2001
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
1 Drug: Sertraline
50 - 200mg, once per day for 12 weeks.
Other Name: Zoloft

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00045773

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United States, Missouri
Washington University School of Medicine
Saint 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
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Principal Investigator: Yvette I. Sheline, M.D. Washington University Psychiatrist
Principal Investigator: Murali Doraiswamy, M.D. Duke University
Additional Information:
Publications of Results:
Other Publications:
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 Y.I. Neuroanatomical changes associated with unipolar major depression. The Neuroscientist 4:331-334, 1998

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Yvette Sheline, Penn Faculty - McLure Professor, University of Pennsylvania Identifier: NCT00045773    
Other Study ID Numbers: R01MH060697 ( U.S. NIH Grant/Contract )
R01MH060697 ( U.S. NIH Grant/Contract )
First Posted: September 11, 2002    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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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