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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00178087
First received: September 13, 2005
Last updated: April 8, 2009
Last verified: April 2009

September 13, 2005
April 8, 2009
August 2005
August 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00178087 on ClinicalTrials.gov Archive Site
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Determining Changes in Brain Structure Associated With Symptoms of Late-Life Depression
Pathways Linking Late-Life Depression to MCI & Dementia

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

150 elderly, non-demented, non-depressed subjects, 60 non-depressed mild cognitive impairment subjects and 270 late-life depression subjects

Late-Life Depression
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
344
August 2010
August 2010   (final data collection date for primary outcome measure)

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.
Both
55 Years and older
Yes
Contact: Meryl A. Butters, Ph.D. 412-246-5280 buttersma@upmc.edu
Contact: Michelle D. Zmuda, B.S. 412-246-6487 zmudamd@upmc.edu
United States
 
NCT00178087
R01 MH072947, 9512127, DATR A4-GPT
Yes
Meryl A. Butters, PhD, University of Pittsburgh
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Meryl A. Butters, Ph.D. University of Pittsburgh
National Institute of Mental Health (NIMH)
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP