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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00178087
First Posted: September 15, 2005
Last Update Posted: April 7, 2015
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.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Meryl Butters, University of Pittsburgh
  Purpose
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
Late-Life Depression

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pathways Linking Late-Life Depression to MCI & Dementia

Further study details as provided by Meryl Butters, University of Pittsburgh:

Primary Outcome Measures:
  • 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


Enrollment: 331
Study Start Date: August 2005
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
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
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00178087


Locations
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)
Investigators
Principal Investigator: Meryl A. Butters, Ph.D. University of Pittsburgh
  More Information

Publications:
Butters MA, Whyte EM, Nebes RD, Begley AE, Dew MA, Mulsant BH, Zmuda MD, Bhalla R, Meltzer CC, Pollock BG, Reynolds CF 3rd, Becker JT. The nature and determinants of neuropsychological functioning in late-life depression. Arch Gen Psychiatry. 2004 Jun;61(6):587-95.
Butters MA, Sweet RA, Mulsant BH, Ilyas Kamboh M, Pollock BG, Begley AE, Reynolds CF 3rd, DeKosky ST. APOE is associated with age-of-onset, but not cognitive functioning, in late-life depression. Int J Geriatr Psychiatry. 2003 Dec;18(12):1075-81.
Butters MA, Becker JT, Nebes RD, Zmuda MD, Mulsant BH, Pollock BG, Reynolds CF 3rd. Changes in cognitive functioning following treatment of late-life depression. Am J Psychiatry. 2000 Dec;157(12):1949-54.
Bell-McGinty S, Butters MA, Meltzer CC, Greer PJ, Reynolds CF 3rd, Becker JT. Brain morphometric abnormalities in geriatric depression: long-term neurobiological effects of illness duration. Am J Psychiatry. 2002 Aug;159(8):1424-7.
Nebes RD, Pollock BG, Houck PR, Butters MA, Mulsant BH, Zmuda MD, Reynolds CF 3rd. Persistence of cognitive impairment in geriatric patients following antidepressant treatment: a randomized, double-blind clinical trial with nortriptyline and paroxetine. J Psychiatr Res. 2003 Mar-Apr;37(2):99-108.
Sweet RA, Hamilton RL, Butters MA, Mulsant BH, Pollock BG, Lewis DA, Lopez OL, DeKosky ST, Reynolds CF 3rd. Neuropathologic correlates of late-onset major depression. Neuropsychopharmacology. 2004 Dec;29(12):2242-50.
Lopez OL, Jagust WJ, DeKosky ST, Becker JT, Fitzpatrick A, Dulberg C, Breitner J, Lyketsos C, Jones B, Kawas C, Carlson M, Kuller LH. Prevalence and classification of mild cognitive impairment in the Cardiovascular Health Study Cognition Study: part 1. Arch Neurol. 2003 Oct;60(10):1385-9.
Lopez OL, Jagust WJ, Dulberg C, Becker JT, DeKosky ST, Fitzpatrick A, Breitner J, Lyketsos C, Jones B, Kawas C, Carlson M, Kuller LH. Risk factors for mild cognitive impairment in the Cardiovascular Health Study Cognition Study: part 2. Arch Neurol. 2003 Oct;60(10):1394-9.
Thompson PM, Hayashi KM, de Zubicaray G, Janke AL, Rose SE, Semple J, Herman D, Hong MS, Dittmer SS, Doddrell DM, Toga AW. Dynamics of gray matter loss in Alzheimer's disease. J Neurosci. 2003 Feb 1;23(3):994-1005.
Ballmaier M, Toga AW, Blanton RE, Sowell ER, Lavretsky H, Peterson J, Pham D, Kumar A. Anterior cingulate, gyrus rectus, and orbitofrontal abnormalities in elderly depressed patients: an MRI-based parcellation of the prefrontal cortex. Am J Psychiatry. 2004 Jan;161(1):99-108.

Responsible Party: Meryl Butters, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00178087     History of Changes
Other Study ID Numbers: R01MH072947 ( U.S. NIH Grant/Contract )
9512127
DATR A4-GPT
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: April 7, 2015
Last Verified: April 2015

Keywords provided by Meryl Butters, University of Pittsburgh:
late-life depression
mild cognitive impairment
dementia

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders


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