Treatment Outcome of Vascular Depression



Status:Completed
Conditions:Depression, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:60 - Any
Updated:11/2/2017
Start Date:April 2001
End Date:April 2006

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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.

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
We found this trial at
2
sites
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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