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Completed

NCT Number: NCT00178087

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

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UPMC Late-Life Evaluation and Treatment Center, Pittsburgh, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Pathways Linking Late-Life Depression to MCI & Dementia

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Sep 15, 2005
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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