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

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00926653

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:

MedlinePlus related topics: Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

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

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

National Institute of Mental Health (NIMH)

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
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on February 12, 2012