Treatment Outcome of Vascular Depression

Depression Clinical Trial

Official title:

Treatment Outcome of Vascular Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00045773
• Other study ID #: R01MH060697
• Secondary ID: R01MH060697DATR
• Status: Completed
• Phase: N/A
• First received: September 9, 2002
• Last updated: October 27, 2017
• Start date: April 2001
• Est. completion date: April 2006

Study information

• Verified date: October 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Sertraline
50 - 200mg, once per day for 12 weeks.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Duke University, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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

Sheline YI, Barch DM, Garcia K, Gersing K, Pieper C, Welsh-Bohmer K, Steffens DC, Doraiswamy PM. Cognitive function in late life depression: relationships to depression severity, cerebrovascular risk factors and processing speed. Biol Psychiatry. 2006 Jul — View Citation

Sheline YI, Black KJ, Lin DY, Christensen GE, Gado MH, Brunsden BS, Vannier MW. Stereological MRI volumetry of the frontal lobe. Psychiatry Res. 1996 Oct 7;67(3):203-14. — View Citation

Sheline YI, Freedland KE, Carney RM. How safe are serotonin reuptake inhibitors for depression in patients with coronary heart disease? Am J Med. 1997 Jan;102(1):54-9. Review. — View Citation

Sheline YI, Price JL, Vaishnavi SN, Mintun MA, Barch DM, Epstein AA, Wilkins CH, Snyder AZ, Couture L, Schechtman K, McKinstry RC. Regional white matter hyperintensity burden in automated segmentation distinguishes late-life depressed subjects from compar — View Citation

External Links

•   Volunteer for Health with Washington University School of Medicine
•   Washington University School of Medicine Psychiatry Department