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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2006-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Depression

Keywords

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Late-Life Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Sertraline

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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P. Murali Doraiswamy, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Washington University in St. Louis

St Louis, Missouri, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED

PMID: 18813343 (View on PubMed)

Other Identifiers

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R01MH062158

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DATR A4-GPX

Identifier Type: -