Sertraline in Depression - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Depression

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

131

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Missouri
  - St. Louis, Missouri, United States, 63130
    - Washington University in St. Louis
- North Carolina
  - Durham, North Carolina, United States, 27706
    - Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measured at Week 12: Montgomery-Asberg Depression Scale (MADRS)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator: P. Murali Doraiswamy, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (ACTUAL)

March 1, 2006

Study Completion (ACTUAL)

March 1, 2006

Study Registration Dates

First Submitted

June 16, 2006

First Submitted That Met QC Criteria