NCT00090831

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2004

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2004

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2012

Completed
Last Updated

December 3, 2019

Status Verified

September 17, 2012

First QC Date

September 3, 2004

Last Update Submit

November 30, 2019

Conditions

Keywords

Emotional LearningNeurotransmitterNeural SystemsResponse ControlOrbitofrontal CortexAmygdalaSerotoninHealthy VolunteerHV

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

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: 1410147BACKGROUND
  • Adolphs R. Neural systems for recognizing emotion. Curr Opin Neurobiol. 2002 Apr;12(2):169-77. doi: 10.1016/s0959-4388(02)00301-x.

    PMID: 12015233BACKGROUND
  • Aron 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

  • James J Blair, Ph.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

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

Locations