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

• ClinicalTrials.gov Identifier: NCT00339066
• Recruitment Status: Completed
• First Posted: June 20, 2006
• Last Update Posted: August 9, 2013
• Sponsor: Duke University
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Duke University

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	Phase
Depression	Drug: Sertraline	Not Applicable

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
• Actual Primary Completion Date: March 2006
• Actual Study Completion Date: March 2006

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

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: 2524; R01MH062158 ( U.S. NIH Grant/Contract ); DATR A4-GPX
• First Posted: June 20, 2006
• Last Update Posted: August 9, 2013
• Last Verified: February 2008

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