Treatment Outcome of Vascular Depression

• ClinicalTrials.gov Identifier: NCT00045773
• Recruitment Status: Completed
• First Posted: September 11, 2002
• Last Update Posted: October 31, 2017
• Sponsor: University of Pennsylvania
• Collaborators: National Institute of Mental Health (NIMH); Duke University
• Information provided by (Responsible Party): Yvette Sheline, University of Pennsylvania

Study Description

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.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

Eligibility Criteria

• 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.

Criteria

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

Locations

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

Investigators

• Principal Investigator: Yvette I. Sheline, M.D.; Washington University Psychiatrist
• Principal Investigator: Murali Doraiswamy, M.D.; Duke University

More Information

Additional Information:

Volunteer for Health with Washington University School of Medicine 

Washington University School of Medicine Psychiatry Department 

Publications of Results:

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 comparison subjects matched for vascular risk factors. Am J Psychiatry. 2008 Apr;165(4):524-32. doi: 10.1176/appi.ajp.2007.07010175. Epub 2008 Feb 15.

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 1;60(1):58-65. Epub 2006 Jan 18.

Other Publications:

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.

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 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.

Sheline Y.I. Neuroanatomical changes associated with unipolar major depression. The Neuroscientist 4:331-334, 1998

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sheline YI, Pieper CF, Barch DM, Welsh-Bohmer K, McKinstry RC, MacFall JR, D'Angelo G, Garcia KS, Gersing K, Wilkins C, Taylor W, Steffens DC, Krishnan RR, Doraiswamy PM. Support for the vascular depression hypothesis in late-life depression: results of a 2-site, prospective, antidepressant treatment trial. Arch Gen Psychiatry. 2010 Mar;67(3):277-85. doi: 10.1001/archgenpsychiatry.2009.204. Erratum in: Arch Gen Psychiatry. 2010 Oct;67(10):1043. Welsh-Boehmer, Kathleen [corrected to Welsh-Bohmer, Kathleen].

• Responsible Party: Yvette Sheline, Penn Faculty - McLure Professor, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT00045773
• Other Study ID Numbers: R01MH060697 ( U.S. NIH Grant/Contract ); R01MH060697 ( U.S. NIH Grant/Contract ); DATR A4-GPX
• First Posted: September 11, 2002
• Last Update Posted: October 31, 2017
• Last Verified: October 2017

Additional relevant MeSH terms:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Sertraline; 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