ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Treatment Outcome of Vascular Depression

This study has been completed.

Sponsors and Collaborators: National Institute of Mental Health (NIMH)
Duke University
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00045773
  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

MedlinePlus related topics:   Depression   

Drug Information available for:   Sertraline hydrochloride    Sertraline   

U.S. FDA Resources

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

Further study details as provided by National Institute of Mental Health (NIMH):

Biospecimen Retention:   None Retained

Biospecimen Description:

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.

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
Genders Eligible for Study:   Both
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

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

Investigators
Principal Investigator:     Yvette I. Sheline, M.D.     Washington University Psychiatrist    
Principal Investigator:     Murali Doraiswamy, M.D.     Duke University    
  More 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 of Results:

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.
 

Responsible Party:   Washington University ( Yvette I. Sheline, MD )
Study ID Numbers:   R01 MH60697, DATR A4-GPX
First Received:   September 9, 2002
Last Updated:   November 10, 2008
ClinicalTrials.gov Identifier:   NCT00045773
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Depression
Mental Disorders
Mood Disorders
Sertraline
Depressive Disorder
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on November 20, 2008




Links to all studies - primarily for crawlers