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Late-Life DepressionNCT00178087

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

An observational study of Late-Life Depression, run by University of Pittsburgh at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for
Late-Life Depression
How many people
331 participants
Where
2 sitesUnited States
Study dates
Aug 2005to Aug 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • Diagnosis of a mood disorder

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • UPMC Late-Life Evaluation and Treatment Center

    Pittsburgh, Pennsylvania, 15213

  • UPMC Western Psychiatric Institute and Clinic

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: 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.

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.

Keywords
late-life depression, mild cognitive impairment, dementia
Medical subject headings
Cognitive Dysfunction, Dementia

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study startAug 2005
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00178087
Sponsor's protocol ID
R01MH072947
Other IDs
R01MH072947, 9512127, DATR A4-GPT
Status last verified
Apr 2015
First submitted
13 Sep 2005
Last updated
7 Apr 2015
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

An observational study of Late-Life Depression, run by University of Pittsburgh at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in performance on a broad-based Neuropsychological Test Battery (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00178087, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.

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