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Effect of Brain Lesion Severity on Treatment Response in Late-Life Depression

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ClinicalTrials.gov Identifier: NCT00339066
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : August 9, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will determine the relationship between brain lesion severity, treatment response, and frontal lobe brain function in people with late-life depression (LLD).

Condition or disease Intervention/treatment
Depression Drug: Sertraline

Detailed Description:

Depression in older adults is a major public health problem and it often goes underdiagnosed and undertreated. A significant number of people with LLD, especially those with cerebrovascular risk factors, have subcortical grey matter and frontal deep white matter brain lesions. Some studies suggest that these lesions, or hyperintensities, may be associated with poor acute and long-term depression treatment response. Similarly, studies have shown that people with LLD frequently have functional deficits in the frontal lobe portion of their brains. This dysfunction has been shown to be associated with poor acute treatment response with a tricyclic antidepressant drug, as well as with a greater risk for depression relapse. The applicability of these findings to other classes of antidepressant medications, such as selective serotonin reuptake inhibitors (SSRIs), however, remains unknown. Additionally, more information is needed about the interaction between frontal brain lesions and executive function deficits in LLD. This study will determine the relationship between brain lesion severity, treatment response, and frontal lobe function in people with late-life depression who are being treated with the SSRI sertraline.

Participants in this open label study will first undergo neuropsychological testing to determine eligibility. All eligible participants will be treated with sertraline for 12 weeks. Dosages will begin at 25 mg per day, and will be increased to 50 mg per day after 4 days. Any other dosage modifications will depend on the participant's individual response to the medication. All participants will have an MRI scan at some point during the study. Assessments of symptoms and treatment response will occur at the study site biweekly until Week 8, and then again at Week 12.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment Outcomes of Vascular Depression
Study Start Date : August 2001
Primary Completion Date : March 2006
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Measured at Week 12: Montgomery-Asberg Depression Scale (MADRS)

Secondary Outcome Measures :
  1. Measured at Week 12: Hamilton Depression Rating Scale (Ham-D)
  2. Clinical Global Impression (CGI)
  3. Quality of Life Assessment
  4. Disability Assessment

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • DSM-IV of major depressive disorder (MDD)
  • Score of greater than 20 on the MADRS (score of greater than 17 for atypical depression)
  • Score of greater than 20 on the Mini Mental State Examination (MMSE)

Exclusion Criteria:

  • Any condition that may make having an MRI medically inadvisable
  • Any severe or unstable medical conditions
  • Any known primary neurological disorders, including history of stroke
  • Any other simultaneous Axis I disorder
  • History of substance or alcohol abuse disorder within 6 months prior to study entry
  • Currently at risk for suicide
  • History of failed prior adequate trials of two antidepressants for the current depressive episode
  • History of failed prior adequate trial of sertraline
  • Current use of any other psychoactive medications (medication washout will be required)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00339066

United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States, 63130
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27706
Sponsors and Collaborators
Duke University
National Institute of Mental Health (NIMH)
Principal Investigator: P. Murali Doraiswamy, MD Duke University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00339066     History of Changes
Other Study ID Numbers: 2524
R01MH062158 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: August 9, 2013
Last Verified: February 2008

Keywords provided by Duke University:
Late-Life Depression

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
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