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Treatment Outcome of Vascular Depression

This study has been completed.
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Duke University
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00045773
First received: September 9, 2002
Last updated: August 29, 2016
Last verified: August 2016

September 9, 2002
August 29, 2016
April 2001
April 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00045773 on ClinicalTrials.gov Archive Site
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Treatment Outcome of Vascular Depression
Treatment Outcome of Vascular Depression
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).

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Adults 60+ with major depression.
  • Depressive Disorder
  • Depression
Drug: Sertraline
50 - 200mg, once per day for 12 weeks.
Other Name: Zoloft
1
Intervention: Drug: Sertraline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
208
April 2006
April 2006   (final data collection date for primary outcome measure)

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
Both
60 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00045773
R01MH060697, R01MH060697, DATR A4-GPX
No
Not Provided
Not Provided
Yvette I. Sheline, MD, Washington University
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
University of Pennsylvania
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP