DepressionNCT00926653
Assessing Anterior Cingulate Brain Activity in People With Late-Life Depression
An observational study of Depression, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Escitalopram
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian-Weill Cornell Medical College
White Plains, New York, 10605
About this study
Official title: Anterior Cingulate Activation in Geriatric Depression
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Escitalopram
- Keywords
- Geriatric Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Lexapro
10 to 20 mg daily as part of another study in which participants are enrolled
| Study group | Role | What they receive |
|---|---|---|
| Depressed | Elderly participants with depression Receives: Drug: Escitalopram | |
| Control | Elderly participants who have never experienced depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral activation, as measured using functional magnetic resonance imaging (fMRI)
Measured: Average of a 2 hour MRI session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startJul 2005
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faith M. Gunning-Dixon, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926653
- Sponsor's protocol ID
- K23MH074818
- Other IDs
- DATR AK-TNGP1
- Status last verified
- Aug 2015
- First submitted
- 22 Jun 2009
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Cingulate Activation in Geriatric Depression
- ClinicalTrials.gov ID
- NCT00926653
- Acronym / sponsor ID
- K23MH074818
- Conditions
- Depression
- Keywords
- Geriatric Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 23 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depressed | – | Drug: EscitalopramElderly participants with depression |
| Control | – | –Elderly participants who have never experienced depression |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EscitalopramAlso: Lexapro10 to 20 mg daily as part of another study in which participants are enrolled | Drug | Depressed |
Primary outcome
Cerebral activation, as measured using functional magnetic resonance imaging (fMRI)
Time frame: Average of a 2 hour MRI session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faith M. Gunning-Dixon, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral activation, as measured using functional magnetic resonance imaging (fMRI) (time frame: Average of a 2 hour MRI session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2015.