Investigating the Role of Serotonin in Emotional Processing Through the Use of Tryptophan Depletion
2 other identifiers
observational
91
1 country
1
Brief Summary
This study will examine the role of serotonin function in the brain. Serotonin, one of the brain's natural chemicals, connects with receptors on brain cells to regulate emotion, anxiety, sleep, stress hormones, and other body functions that are disturbed in various mood and anxiety disorders. Also, the research will look at the function of particular brain areas, how they are involved in regulating emotions, and how serotonin is involved in the regulation of their function. The procedures entailed are tryptophan depletion and magnetic resonance imagining (MRI). Also, researchers' understanding of the genetic causes of mood and anxiety disorders will increase through examination of participants' DNA. Adults in good health, ages 20 through 50, may be eligible for this study. Among those not eligible are females who are pregnant or breast feeding, patients with psychiatric or central nervous system disease, and those taking medications that would interfere with study results. At the first visit, patients will be asked about their general mood, degree of nervousness, thinking skills, and behavior. The session will last from 1.5 to 2.0 hours. A blood sample of about 2 tablespoons will be drawn, for DNA study. Participants will undergo the following procedures and tests:
- Physical examination.
- Test of vital signs, lying and standing.
- Electrocardiogram.
- Collection of blood for chemistry and hematology.
- Urinalysis.
- HIV, urine drug, and hepatitis screening.
- Psychiatric screening.
- (SqrRoot) -HCG pregnancy test, if applicable. At the second visit, patients will receive either tryptophan depletion or placebo, and 5 hours later, the study will begin, to last up to 2 additional hours. Patients will be asked periodically about their emotional state or changes in their well-being. The MRI system will create images of the brain's blood flow and measure glucose metabolism as a measure of brain activity. During the MRI scan, patients will hear knocking or beeping sounds, and they will wear earplugs to reduce the noise. Patients will be able to communicate with the MRI staff at all times during the scan, and they may ask to be moved out of the machine at any time. The MRI session lasts up to 1.5 hours. Results of any medical tests or other information will not be provided to participants, because further research may be needed before such results are meaningful. But if meaningful information develops from this study that may be important for a participant's health, he or she will be notified about it when it becomes available.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2004
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 31, 2004
CompletedFirst Submitted
Initial submission to the registry
September 3, 2004
CompletedFirst Posted
Study publicly available on registry
September 6, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 17, 2012
CompletedDecember 3, 2019
September 17, 2012
September 3, 2004
November 30, 2019
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Age: Participants will be males and females, 20-50 years of age.
- IQ: IQ, as measured by 4 subscales from the Wechsler Adult Intelligence Scale-Revised (WAIS-R), must be greater than 80.
- Participants will be able to comprehend the purpose and procedures of the study. They will be able to provide written, informed consent for all study procedures.
You may not qualify if:
- Psychiatric history: Participants will be assessed using DSM-IV criteria via standardized psychiatric interviews conducted by trained examiners (SCID). All participants will be free of any current or past major affective disorder, psychotic disorder, substance dependence, anorexia nervosa or bulimia. All participants will be free of any current anxiety disorders with the exception of specific phobias and free of current somatoform disorders. In addition, participants with a first degree relative with major depressive disorder will be excluded.
- Severe acute and chronic medical illnesses (e.g., cardiac disease, diabetes, epilepsy).
- CNS disease: History of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), or other neurological disease, or history of head trauma (defined as loss of consciousness greater than 3 min).
- Currently on any regular medication that would interfere with study results (with exception of contraceptive pill).
- Current use of psychotropic medication or benzodiazepine
- Currently breast feeding or pregnant (as documented by pregnancy testing done within 24 hr of the study starting)
- Subjects who are lactose intolerant will be excluded as the placebo capsules contain lactose. Also, those subjects who cannot consume the diets provided by metabolic nutrition on the study day will be excluded.
- Metal or electronic objects: Metal plates, certain types of dental braces, cardiac pacemakers, etc., that are sensitive to electromagnetic fields contraindicate MRI scans.
- Claustrophobia: participants will be questioned about potential discomfort in being in an enclosed space, such as an MRI scanner.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (3)
Abbott FV, Etienne P, Franklin KB, Morgan MJ, Sewitch MJ, Young SN. Acute tryptophan depletion blocks morphine analgesia in the cold-pressor test in humans. Psychopharmacology (Berl). 1992;108(1-2):60-6. doi: 10.1007/BF02245286.
PMID: 1410147BACKGROUNDAdolphs R. Neural systems for recognizing emotion. Curr Opin Neurobiol. 2002 Apr;12(2):169-77. doi: 10.1016/s0959-4388(02)00301-x.
PMID: 12015233BACKGROUNDAron AR, Fletcher PC, Bullmore ET, Sahakian BJ, Robbins TW. Stop-signal inhibition disrupted by damage to right inferior frontal gyrus in humans. Nat Neurosci. 2003 Feb;6(2):115-6. doi: 10.1038/nn1003. No abstract available.
PMID: 12536210BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
James J Blair, Ph.D.
National Institute of Mental Health (NIMH)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
September 3, 2004
First Posted
September 6, 2004
Study Start
August 31, 2004
Study Completion
September 17, 2012
Last Updated
December 3, 2019
Record last verified: 2012-09-17