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CompletedNCT00178087Updated Apr 7, 2015

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

An observational study in Late-Life Depression, sponsored by University of Pittsburgh. Completed at 2 sites in United States. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-07.

Sponsored by University of Pittsburgh · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
331
Ages
55 Years and older
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Late-Life Depression

Keywords

  • late-life depression
  • mild cognitive impairment
  • dementia
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In context

Cognitive Dysfunction

3,930 studies on the registry are indexed under Cognitive Dysfunction; 1,114 are open to participants now.

This study's enrollment of 331 is above the median of 150 across 989 observational studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,414 studies on the registry; 168 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years and older
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of a mood disorder

Exclusion criteria

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
331 participants (actual)
06

What researchers measure

Primary outcomes

  1. Changes in performance on a broad-based Neuropsychological Test Battery

    Changes in z-scores of the language, visuospatial, attention, memory and executive cognitive domains

    Time frame: 3 years

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Study locations

2 sites
  • UPMC Late-Life Evaluation and Treatment Center
    Pittsburgh, Pennsylvania 15213, United States
  • UPMC Western Psychiatric Institute and Clinic
    Pittsburgh, Pennsylvania 15213, United States
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References and documents

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. doi: 10.1001/archpsyc.61.6.587. PubMed 15184238 ↗
  • 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. doi: 10.1002/gps.1006. PubMed 14677138 ↗
  • 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. doi: 10.1176/appi.ajp.157.12.1949. PubMed 11097959 ↗
  • 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. doi: 10.1176/appi.ajp.159.8.1424. PubMed 12153839 ↗
  • 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. doi: 10.1016/s0022-3956(02)00085-7. PubMed 12842163 ↗
  • 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. doi: 10.1038/sj.npp.1300554. PubMed 15354182 ↗
  • 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. doi: 10.1001/archneur.60.10.1385. PubMed 14568808 ↗
  • 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. doi: 10.1001/archneur.60.10.1394. PubMed 14568809 ↗
  • 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. doi: 10.1523/JNEUROSCI.23-03-00994.2003. PubMed 12574429 ↗
  • 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. doi: 10.1176/appi.ajp.161.1.99. PubMed 14702257 ↗

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00178087
Responsible party
Meryl Butters (Associate Professor, University of Pittsburgh) — Principal investigator
First posted
Sep 15, 2005
Start date
Aug 2005
Primary completion
Aug 2011
Completion
Aug 2011
Last update
Apr 7, 2015

Study contacts

Meryl A. Butters, Ph.D.
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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