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

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 Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Treatment Outcomes 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 Duke University:

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


Enrollment:	131
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 (Adult, Senior)
Sexes Eligible for Study:	All
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

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: 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

Duke University

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	P. Murali Doraiswamy, MD	Duke University

More Information

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

Taylor WD, Kuchibhatla M, Payne ME, Macfall JR, Sheline YI, Krishnan KR, Doraiswamy PM. Frontal white matter anisotropy and antidepressant remission in late-life depression. PLoS One. 2008 Sep 24;3(9):e3267. doi: 10.1371/journal.pone.0003267.


Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT00339066 History of Changes
Other Study ID Numbers:	2524 R01MH062158 ( US NIH Grant/Contract Award Number ) DATR A4-GPX
Study First Received:	June 16, 2006
Last Updated:	August 7, 2013

Keywords provided by Duke University:


Late-Life Depression

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 June 28, 2017