- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00926653
Assessing Anterior Cingulate Brain Activity in People With Late-Life Depression
Anterior Cingulate Activation in Geriatric Depression
Study Overview
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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White Plains, New York, United States, 10605
- New York Presbyterian-Weill Cornell Medical College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Depressed
Elderly participants with depression
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10 to 20 mg daily as part of another study in which participants are enrolled
Other Names:
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Control
Elderly participants who have never experienced depression
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cerebral activation, as measured using functional magnetic resonance imaging (fMRI)
Time Frame: Average of a 2 hour MRI session
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Average of a 2 hour MRI session
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Collaborators and Investigators
Investigators
- Principal Investigator: Faith M. Gunning-Dixon, PhD, Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- K23MH074818 (U.S. NIH Grant/Contract)
- DATR AK-TNGP1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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