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).

Completed

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Key information

Conditions

Depressive Disorder Behavior Behavioral Symptoms Depression Mental Disorders Mood Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine, St Louis, Missouri, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sertraline

Drug

50 - 200mg, once per day for 12 weeks.

Other names: Zoloft

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

Duke University
National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start: 2001
Primary completion: 2006
Study completion: 2006
First posted: Sep 11, 2002
Registry last updated: Oct 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed