NIH Clinical Research Studies

Protocol Number: 04-M-0136

Active Followup, Protocols NOT Recruiting New Patients

Title:
Neurocardiac Control in Major Depression
Number:
04-M-0136
Summary:
This study will examine how depression may influence the way the brain regulates heart function. Some researchers believe that depression may be a risk factor for some forms of heart disease.

Right-handed healthy volunteers and patients with major depressive disorder who are between 18 and 50 years of age may be eligible for this study. Female candidates must be premenopausal. Patients must currently be experiencing a major depressive episode. All candidates are screened with a medical history and physical examination, electrocardiogram, and blood and urine tests. They are interviewed about their psychiatric and medical history, current emotional state and sleep pattern, and family history of psychiatric disorders. They complete symptoms ratings scales for depression, anxiety, and negative thinking; history of alcohol and tobacco use; level of physical activity; socioeconomic status; overall level of functioning; and, for depressed patients, their depression type. Women candidates have their menstrual phase determined by the timing of their recent menstrual cycles and may undergo testing to determine the time of their ovulation.

Participants undergo the following tests and procedures:

- 12-minute walk/run test - This test measures the subject's general level of cardiorespiratory fitness. In a gymnasium in the NIH Clinical Center, the subject walks or runs as far as he or she can in 12 minutes. Blood pressure is measured before and after the exercise test, and heart rate is measured during exercise with a monitor worn around the chest.

- Magnetic resonance imaging (MRI) - A brain MRI scan is done to obtain pictures of the brain anatomy. Electrocardiogram leads are placed on the subject's chest to measure the electrical activity of the heart during the scanning session. The subject lies on a narrow bed in the scanner, which is a narrow metal cylinder about 6 feet long. The scanning session takes up to 90 minutes.

- Positron emission tomography (PET) - PET scanning produces images of the brain's blood flow. The subject is injected with a radiotracer (small amount of drug labeled with a radioactive substance) that is detected by a special camera to trace blood flow. During the scanning session, the subject lies still on a table. EKG leas are placed on the subject's chest to measure the electrical activity of the heart during the scan. A mask with holes for the eyes, ears, and mouth is placed over the subject's face to keep the head from moving. The subject undergoes a series of 14 or 15 scans, with the radiotracer injected while the subject performs memory and exercise tasks. For the memory task, the subject is shown a series of letters and is asked to press a button when a target letter appears. In the exercise task, the subject repeatedly squeezes a hand-grip device according to instructions from a computer. The PET scanner detects the radiotracer in brain areas during each scan that shows blood flow and brain activity. The scanning session takes about 3-1/2 hours.

Sponsoring Institute:
National Institute of Mental Health (NIMH)
Recruitment Detail
Type: Completed Study; data analyses ongoing
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
Special Instructions:
Currently Not Provided
Keyword(s):
PET
Heart Rate Variability
N-Back Task
Isometric Handgrip
MRI
Depression
Recruitment Keyword(s):
Depression
MDD
Heart
Condition(s):
Depression, Involutional
Investigational Drug(s):
[0-15] Water
Investigational Device(s):
None
Interventions:
None
Supporting Site:
National Institute of Mental Health

Contact(s):
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):
Rozanski A, Blumenthal JA, Kaplan J. Impact of psychological factors on the pathogenesis of cardiovascular disease and implications for therapy. Circulation. 1999 Apr 27;99(16):2192-217. Review.

Billman GE. Left ventricular dysfunction and altered autonomic activity: a possible link to sudden cardiac death. Med Hypotheses. 1986 May;20(1):65-77.

Hull SS Jr, Evans AR, Vanoli E, Adamson PB, Stramba-Badiale M, Albert DE, Foreman RD, Schwartz PJ. Heart rate variability before and after myocardial infarction in conscious dogs at high and low risk of sudden death. J Am Coll Cardiol. 1990 Oct;16(4):978-85.

Active Followup, Protocols NOT Recruiting New Patients

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