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Assessing Anterior Cingulate Brain Activity in People With Late-Life Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 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:
NCT00926653
First received: June 22, 2009
Last updated: June 29, 2009
Last verified: June 2009
  Purpose

This study will examine differences in activity of the anterior cingulate cortex, a brain area involved in emotion and cognitive regulation, between older adults with and without depression.


Condition Intervention
Depression
Drug: Escitalopram

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Anterior Cingulate Activation in Geriatric Depression

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Cerebral activation, as measured using functional magnetic resonance imaging (fMRI) [ Time Frame: Measured once ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: July 2005
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Depressed
Elderly participants with depression
Drug: Escitalopram
10 to 20 mg daily as part of another study in which participants are enrolled
Other Name: Lexapro
Control
Elderly participants who have never experienced depression

Detailed Description:

Older adults with depression often also suffer from executive dysfunction—problems with planning, impulse control, and reasoning. Executive dysfunction in older adults predicts poor or delayed response to antidepressant treatment and has been associated with early relapse and recurrence of late-life major depression. Functional magnetic resonance imaging (fMRI) is a scan that can measure the activity of someone's brain while that person performs tasks. So far, no fMRI studies investigating cerebral activation patterns in late-life depression have been published. In this study, people will undergo fMRI while they are performing an executive function task. Older adults with late-life depression and older adults without depression will be tested and compared in order to identify the areas and patterns of brain activity underlying executive dysfunction in late-life depression.

Participation in this study will consist of one study visit, during which participants will undergo an fMRI scan that will last 60 to 90 minutes. While being scanned, participants will perform cognitive tasks that involve pressing buttons in response to words viewed on a screen.

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Depressed and control participants are recruited from the community, with additional depressed participants recruited from a geriatric outpatient clinic at New York Presbyterian/Weill Cornell Medical College.

Criteria

Inclusion Criteria for Depressed Participants:

  • Diagnosis of major depression by DSM-IV criteria
  • Mini-Mental State Examination (MMSE) score greater than 24
  • Severity score of 17 or higher on the 21-item Hamilton Depression Rating Scale score (HDRS) during the index episode
  • Residence less than a 45-minute drive from New York Hospital-Westchester Division

Exclusion Criteria for Depressed Participants:

  • Presence of psychotic depression, as defined by Research Diagnostic Criteria and DSM-IV
  • History of psychiatric disorders other than unipolar major depression (people with bipolar disorder and dysthymia will be excluded)
  • Presence of dementing disorders
  • Acute or severe medical illness, such as the following: delirium; metastatic cancer; decompensated cardiac, liver, or kidney failure; major surgery; or cerebrovascular accident or myocardial infarction 3 months prior to study entry
  • Receiving drugs known to cause depression, including reserpine, alpha-methyl-dopa, and steroids
  • Requires concomitant treatment with other psychotropics, including antipsychotic medications, lithium salts, stimulants, valproic acid, carbamazepine, or gabapentin
  • Severe aphasia interfering with communication
  • Contraindications to magnetic resonance (MR) scanning, such as implanted metal, claustrophobia, or weight greater than or equal to 300 lbs

Inclusion Criteria for Age-Matched Non-Psychiatric Comparison Sample:

  • MMSE score greater than 24

Exclusion Criteria for Age-Matched Non-Psychiatric Comparison Sample:

  • History of psychiatric disorder
  • Presence of dementing disorders
  • Acute or severe medical illness, such as the following: delirium; metastatic cancer; decompensated cardiac, liver, or kidney failure; major surgery; or cerebrovascular accident or myocardial infarction 3 months prior to study entry
  • Receiving drugs known to cause depression, including reserpine, alpha-methyl-dopa, and steroids
  • Current treatment with psychotropics
  • Severe aphasia interfering with communication
  • Contraindications to MR scanning, such as implanted metal, claustrophobia, or weight greater than or equal to 300 lbs
  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: NCT00926653

Contacts
Contact: Shizuko Morimoto, PsyD 914-997-5413 ssm9006@med.cornell.edu

Locations
United States, New York
New York Presbyterian-Weill Cornell Medical College Recruiting
White Plains, New York, United States, 10605
Contact: Shizuko Morimoto, PsyD    914-997-5413    ssm9006@med.cornell.edu   
Principal Investigator: Faith M. Gunning-Dixon, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Faith M. Gunning-Dixon, PhD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Faith M. Gunning-Dixon, PhD, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00926653     History of Changes
Other Study ID Numbers: K23 MH074818, DATR AK-TNGP1
Study First Received: June 22, 2009
Last Updated: June 29, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Geriatric Depression

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

ClinicalTrials.gov processed this record on November 27, 2014