Neurocognitive Outcomes of Depression in the Elderly (NCODE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Mississippi Medical Center
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00570583
First received: December 7, 2007
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

This study seeks to examine clinical, genetic, and neuroanatomical variables related to mood and cognitive outcomes of depression in late life. We plan to study the following SPECIFIC AIMS:

Aim 1. To compare cognitive outcomes among older adults with and without depression, and to examine depression and cognitive outcomes in patients with cognitive impairment or neuroimaging changes.

Aim 2. To examine the role of genes in long-term depression outcomes in the elderly.

Aim 3. To determine neuroanatomical and neuropathological correlates of late-life depression outcomes.


Condition
Major Depression
Dementia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Geriatric Depression: Risk Factors for Adverse Outcomes

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in Depression status (measured by Montgomery Asberg Depression Rating Scale) [ Time Frame: Minimum of once per year, up to 21 years ] [ Designated as safety issue: No ]
  • Change in Cognitive impairment (as measuring using cognitive tests including those found in the CERAD battery) [ Time Frame: Once per year, up to 21 years ] [ Designated as safety issue: No ]
  • Development of dementia (Determined by Clinical Consensus Conference) [ Time Frame: once per year, up to 14 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Cognition (as measured by tests including those in the CERAD battery) Change in Brain MRI markers (e.g., volume of white matter and gray matter lesions) [ Time Frame: once per year, up to 21 years ] [ Designated as safety issue: No ]
  • Change in Impairment in Instrumental or Basic Activities of Daily Living [ Time Frame: at least once per year, up to 21 years ] [ Designated as safety issue: No ]
  • Packing density of prefrontal cortex neurons with pyramidal morphology in post-mortem neuroanatomical studies [ Time Frame: once post-mortem ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

serum, white cells


Estimated Enrollment: 795
Study Start Date: December 1995
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Depressed
Older individuals with major depression
Non-depressed
Older individuals without psychiatric disorder

Detailed Description:

We will test the following hypotheses:

Hypothesis 1. Compared with non-depressed elderly controls, depressed elderly patients will have an increased incidence of development of mild cognitive impairment and dementia.

Hypothesis 2. Depressed subjects with mild cognitive impairment will have a worse depression course compared with depressed subjects who do not have mild cognitive impairment.

Hypothesis 3. Depressed subjects with worsening deep white matter disease and smaller hippocampal volumes on longitudinal (baseline to two year) magnetic resonance imaging brain scans will have a worse depression course and more cognitive decline compared with depressed subjects without these brain changes.

Hypothesis 4. Depressed subjects with the 5HTTLPR short allele will have a worse depression course compared with depressed subjects without these risk genes.

Hypothesis 5. Depressed subjects with the apolipoprotein E (APOE) epsilon-4 allele and vascular risk gene polymorphisms such as ACE receptor will have an increased risk of cognitive decline compared with depressed subjects without these risk genes.

Hypothesis 6. Compared with brains of non-depressed controls, brains of depressed subjects will demonstrate increased density of blood vessels in the prefrontal cortex, including orbital frontal cortex and dorsolateral prefrontal cortex.

Hypothesis 7. Compared with brains of non-depressed controls, brains of depressed subjects will demonstrate decreased packing density of prefrontal cortex neurons with pyramidal morphology.

Hypothesis 8. Compared with non-demented depressed subjects, depressed individuals who become demented will have more neuritic plaques, neurofibrillary tangles and cerebrovascular pathology.

We will examine secondary aims related to 1) mortality and 2) social factors, with the following hypotheses:

  1. Depressed subjects with a larger increase in volume of hyperintensities will have a higher mortality rate.
  2. Subjects with poor social support and functional status will have worse depression and cognitive outcomes.
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic Outpatient psychiatry clinic Inpatient psychiatry clinic Self-referral

Criteria

Inclusion Criteria:

For depressed group:

  1. Age > 60 years
  2. Major depression, single episode or recurrent
  3. Ability to read and write English
  4. MMSE >25
  5. Willingness to participate in the follow-up study for at least two years.

For non-depressed group:

  1. Age > 60 years
  2. Ability to read and write English
  3. MMSE >25
  4. Willingness to participate in the follow-up study for at least two years.

Exclusion Criteria:

  1. Lifetime alcohol or drug dependence
  2. conditions associated with MRI abnormalities such hydrocephalus, benign and cancerous brain tumors, epilepsy, Parkinson's disease, Huntington's chorea, dementia, demyelinating diseases, etc.
  3. endocrine disorder other than diabetes mellitus)
  4. Any physical or intellectual disability that may affect completion of self rating instruments
  5. Established clinical diagnosis of dementia
  6. Other primary psychiatric disorders, including panic disorder, social phobia, OCD, non-affective psychosis (including schizo-affective disorder), schizophrenia, bipolar disorder
  7. Any metal or pacemaker in the body which precludes MRI.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570583

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
University of Mississippi Medical Center
Investigators
Principal Investigator: John L Beyer, MD Duke University
  More Information

Additional Information:
Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00570583     History of Changes
Other Study ID Numbers: Pro00006424, R01MH054846, 0625
Study First Received: December 7, 2007
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Depression
Cognitive impairment
Dementia
Neuroimaging
Genetics

Additional relevant MeSH terms:
Dementia
Depression
Depressive Disorder
Depressive Disorder, Major
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on April 15, 2014