- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00014027
Effect of Polyunsaturated Fatty Acids on Cardiovascular and Motor Responses Under Stress
Polyunsaturated Fatty Acids and the Neurochemistry of Cardiovascular and Behavioral Responses in Aggressive Alcoholics
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
A primary diagnosis of alcohol dependence within the last three months.
Male or female research participants with a Coccaro Lifetime History of Aggression score of 20 or more.
Reported consumption of seafood no greater than twice per week.
Age of 18 years or older.
Must have been sober for 21-60 days.
Laboratory history and physical exam findings that are without significant abnormalities (significant abnormality would include laboratory deviations that require medical intervention or that indicate a major medical disorder).
EKG and chest X-ray are without clinically significant abnormalities as determined by the physician interpreting the studies.
Educational level and degree of understanding that is sufficient to provide informed consent, sign the consent forms and to allow for clear and intelligent communication between research participant, investigators and staff.
EXCLUSION CRITERIA:
Lifetime history of an axis I psychiatric disorders specifically psychotic, schizophrenic, bipolar affective disorder type I or eating disorders or premenstrual phase dysphoric disorder. Major depression, depressive disorder NOS, panic and other anxiety disorders are not exclusionary. Axis II personality disorders are not exclusionary.
Major medical disorders or major neurological disorders.
Determination by the Principal Investigator that the subject's use of prescription or illicit drugs within the last six months will interfere with the dependent endpoints of the study.
Regular use of prescription medications with psychotropic effects including side effects or medications that modify lipid metabolism, within the last month. Use of NSAIDS, aspirin or Tylenol not more than five times total per week, will be allowed.
Current psychotherapy to reduce aggression or depression.
Extensive use of home remedies, vitamins or nutritional supplements within three months. Use of multi-vitamins one time per day will be allowed.
Pacemaker or other metal implants, which might be a contraindication for a MRI, scan.
Laboratory tests which indicate presence of the HIV.
Pregnancy.
Allergy to fish or seafood.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Publications and helpful links
General Publications
- Adams PB, Lawson S, Sanigorski A, Sinclair AJ. Arachidonic acid to eicosapentaenoic acid ratio in blood correlates positively with clinical symptoms of depression. Lipids. 1996 Mar;31 Suppl:S157-61. doi: 10.1007/BF02637069.
- Apter A, Plutchik R, van Praag HM. Anxiety, impulsivity and depressed mood in relation to suicidal and violent behavior. Acta Psychiatr Scand. 1993 Jan;87(1):1-5. doi: 10.1111/j.1600-0447.1993.tb03321.x.
- Akselrod S, Gordon D, Madwed JB, Snidman NC, Shannon DC, Cohen RJ. Hemodynamic regulation: investigation by spectral analysis. Am J Physiol. 1985 Oct;249(4 Pt 2):H867-75. doi: 10.1152/ajpheart.1985.249.4.H867.
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 010141
- 01-AA-0141
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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