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Determining Changes in Brain Structure Associated With Symptoms of Late-life Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00178087
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : April 7, 2015
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Meryl Butters, University of Pittsburgh

Brief Summary:
This study will determine the changes in brain structure and function that are responsible for mood and cognition changes that are sometimes associated with late-life depression.

Condition or disease
Late-Life Depression

Detailed Description:
The goal of this research study is to investigate the relationships among late-life depression (LLD), cognitive impairment and progressive neurodegeneration. The guiding hypothesis is that LLD patients have evolving cognitive impairments as a consequence of distinct underlying neuropathological changes, which frequently are expressed as Mild Cognitive Impairment (MCI). These neuropathological and cognitive changes are risk modifiers, lowering brain reserve capacity, and in turn, increasing risk of developing Alzheimer's Disease (AD). In order to pursue this goal we will enroll LLD, MCI, and normal control subjects to enrich our existing cohort to include a total of 150 elderly, non-demented, non-depressed subjects, 60 non-depressed MCI subjects and 270 LLD subjects. Using the joint infrastructure of the University of Pittsburgh's Advanced Center for Intervention and Services Research for Late-Life Mood Disorders and the Alzheimer's Disease Research Center, we will complete a detailed neurobehavioral evaluation, including clinical, neuropsychological, neuroimaging and biological markers, using these data to evaluate the factors associated with the development of MCI or dementia. Subjects will be studied annually for at least three years, allowing us to use longitudinal data to evaluate a series of linked hypotheses that postulate the pathways by which elderly, depressed patients develop cognitive impairment, and which may lead some to develop dementia.

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Study Type : Observational
Actual Enrollment : 331 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Pathways Linking Late-Life Depression to MCI & Dementia
Study Start Date : August 2005
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Changes in performance on a broad-based Neuropsychological Test Battery [ Time Frame: 3 years ]
    Changes in z-scores of the language, visuospatial, attention, memory and executive cognitive domains

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
150 elderly, non-demented, non-depressed subjects, 60 non-depressed mild cognitive impairment subjects and 270 late-life depression subjects

Inclusion Criteria:

  • Diagnosis of a mood disorder

Exclusion Criteria:

  • Major acute medical illnesses or injuries known to have significant direct effects on cognitive functioning (e.g., metastatic cancer, multiple sclerosis, traumatic brain injury).
  • Uncorrectable sensory handicap (e.g., blindness), because they are unable to complete the cognitive test battery.
  • Exclusion criteria for MR scans include: cardiac pacemaker, aneurysm clip, cochlear implant, pregnancy, IUD, shrapnel, history of metal fragments in the eye, neurostimulators, weight of 250 lbs. or more, or claustrophobia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00178087

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United States, Pennsylvania
UPMC Late-Life Evaluation and Treatment Center
Pittsburgh, Pennsylvania, United States, 15213
UPMC Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute of Mental Health (NIMH)
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Principal Investigator: Meryl A. Butters, Ph.D. University of Pittsburgh

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Responsible Party: Meryl Butters, Associate Professor, University of Pittsburgh Identifier: NCT00178087    
Other Study ID Numbers: R01MH072947 ( U.S. NIH Grant/Contract )
R01MH072947 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015
Keywords provided by Meryl Butters, University of Pittsburgh:
late-life depression
mild cognitive impairment
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders