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
  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

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment: 344
Study Start Date: August 2005
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178087

Contacts
Contact: Meryl A. Butters, Ph.D. 412-246-5280 buttersma@upmc.edu
Contact: Michelle D. Zmuda, B.S. 412-246-6487 zmudamd@upmc.edu

Locations
United States, Pennsylvania
UPMC Western Psychiatric Institute and Clinic Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Meryl A. Butters, Ph.D.    412-246-5280    buttersma@upmc.edu   
Contact: Michelle D. Zmuda, B.S.    412-246-6487    zmudamd@upmc.edu   
Principal Investigator: Meryl A. Butters, Ph.D.         
Sub-Investigator: Benoit H. Mulsant, M.D.         
Sub-Investigator: Robert A. Sweet, M.D.         
Sub-Investigator: Charles F. Reynolds, III., M.D.         
Sub-Investigator: James T. Becker, Ph.D.         
Sub-Investigator: Mark Miller, M.D.         
Sub-Investigator: Carolyn C. Meltzer, M.D.         
Sub-Investigator: Howard Aizenstein, M.D., Ph.D.         
UPMC Late-Life Evaluation and Treatment Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jacqueline A. Stack, MSN,RN,CSN    412-246-6006    stackja@upmc.edu   
Contact: Jill A. Houle, B.A.    412-246-6003    houleja@upmc.edu   
Principal Investigator: Meryl A. Butters, Ph.D.         
Sub-Investigator: Charles F. Reynolds, III., M.D.         
Sponsors and Collaborators
Investigators
Principal Investigator: Meryl A. Butters, Ph.D. University of Pittsburgh
  More Information

Publications:

Responsible Party: Meryl A. Butters, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00178087     History of Changes
Other Study ID Numbers: R01 MH072947, 9512127, DATR A4-GPT
Study First Received: September 13, 2005
Last Updated: April 8, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
late-life depression
mild cognitive impairment
dementia

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

ClinicalTrials.gov processed this record on September 30, 2014