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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00339066
First received: June 16, 2006
Last updated: February 12, 2008
Last verified: February 2008
History of Changes
  Purpose

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 Intervention
Depression
 Drug: Sertraline

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment Outcomes of Vascular Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

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

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

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

Estimated Enrollment: 360
Study Start Date: August 2001
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00339066

Locations
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
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: P. Murali Doraiswamy, MD Duke University
  More Information

No publications provided by National Institute of Mental Health (NIMH)

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

ClinicalTrials.gov Identifier: NCT00339066     History of Changes
Other Study ID Numbers: R01 MH62158, DATR A4-GPX
Study First Received: June 16, 2006
Last Updated: February 12, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Late-Life Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013