Treatment Outcome of Vascular Depression - Full Text View

Purpose

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	Intervention
Depressive Disorder Depression	Drug: Sertraline


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Treatment Outcome of Vascular Depression

Resource links provided by NLM:

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:


Enrollment:	208
Study Start Date:	April 2001
Study Completion Date:	April 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1	Drug: Sertraline 50 - 200mg, once per day for 12 weeks. Other Name: Zoloft

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.

Eligibility


Ages Eligible for Study:	60 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Adults 60+ with major depression.

Criteria

Inclusion Criteria:

Ages 60+
DSM-IV criteria for MDD
Hamilton Depression Rating Scale score >18
No MRI contraindications, e.g. foreign metallic implants, pacemaker
Medication free of any psychotropic drug except as otherwise noted for set washout period (see D.2.1)
Mini Mental Status Exam score <21
No unstable medical disorders (requiring immediate medical attention)
Ability to give informed consent
English speaking

Exclusion Criteria:

Age <60
Does not meet DSM-IV criteria for MDD
Hamilton Depression Rating Scale score <18
MRI contraindications e.g. foreign metallic implants, pacemaker
Psychotropic drug use other than zolpidem and lorazepam, prn within 2 weeks of entry
Mini Mental Status Exam score >21, or known primary neurological disorders including Dementia of the Alzheimer type, Parkinson's Disease, multiple sclerosis, seizure disorder.
Unstable medical disorders, uncorrected hypothyroidism, or any condition that in the investigators opinion makes the patients unsuitable for a trial
Cannot give informed consent
Does not speak English

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045773

Locations


United States, Missouri
Washington University School of Medicine
St. 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 This link exits the ClinicalTrials.gov site

Washington University School of Medicine Psychiatry Department This link exits the ClinicalTrials.gov site

Publications:

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.

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 I. Sheline, MD, Washington University
ClinicalTrials.gov Identifier:	NCT00045773 History of Changes
Other Study ID Numbers:	R01MH060697 DATR A4-GPX
Study First Received:	September 9, 2002
Last Updated:	August 29, 2016
Health Authority:	United States: Federal Government

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

ClinicalTrials.gov processed this record on September 28, 2016