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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00059046 |
Serotonin is a chemical involved in the regulation of emotions, anxiety, sleep, stress, and other body functions. The purpose of this study is to use brain imaging technology to study how serotonin works in the brain.
The serotonin transporter (SERT) regulates the release of sertonin throughout the body. Until recently, radioactive chemicals called tracers were not suitable for viewing SERT activity. However, a newly developed tracer called [11C]DASB can be used with positron emission tomography (PET) imaging to view the parts of the brain that use serotonin.
Participants in this study will be screened with medical and psychiatric examinations, an electrocardiogram (EKG), and blood and urine tests. This study comprises two parts. During Part 1, participants will undergo a whole-body PET scan. During Part 2, participants will undergo a magnetic resonance imaging (MRI) scan of the brain. At the next study visit, participants will have one or two PET head scans. If not is not possible to perform both scans on the same day, an additional visit will be scheduled for the second PET scan.
Condition |
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Healthy Serotonin Transporter |
Study Type: | Observational |
Official Title: | Kinetic Studies in Whole Body and Brain of [11C]DASB PET Imaging of Serotonin Transporters |
Estimated Enrollment: | 20 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | January 2005 |
The serotonin transporter (SERT) modulates the activity of the central serotonergic system and SERT is also the primary target of the widely prescribed specific serotonin reuptake inhibitors. Until recently, suitable radioligands for in vivo imaging of SERT have not been available. However, a recently developed PET radioligand, [11C]DASB, appears suitable for quantifying SERT in humans. In the two protocols that have been approved by the CSRP for submission to the IRB, we planned to use [11C]DASB PET to study the pathophysiology of SERT in Parkinson's disease and OCD. This protocol was created to address criticisms raised by the NIH RDRC committee and the external scientific review.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA: WHOLE BODY IMAGING
Diagnosis: Healthy
Ages: 18-50 years
EXCLUSION CRITERIA: WHOLE BODY IMAGING
History of psychiatric disease, substance dependence or traumatic brain injury, severe systemic disease, poor vision or hearing.
History of substance abuse within 6 months
Abnormal laboratory tests, including HIV test
Any prior participation in other research protocols involving radiation exposure within the past year
Prior participation in other research protocols within the past year such that a radiation exposure together with the present study would exceed the annual limits
Pregnancy and Breast Feeding
Positive HIV test
INCLUSION CRITERIA: PART 2 KINETIC
Age: 18-50 y
Male or female
Consent given
EXCLUSION CRITERIA: PART 2 KINETIC
DSM-IV Axis I diagnostic criteria such as history of, or current diagnosis ADHD, mood/anxiety disorder, alcohol or psychoactive substance abuse/dependence. All subjects must meet none of the Axis I diagnoses.
Psychotropic medication or other drugs that may cross the blood brain barrier. Drug free period must be greater than 4 weeks (antidepressants and benzodiazepine) and greater than 6 weeks (fluoxetine, antipsychotics, anticonvulsants).
Pregnancy or breastfeeding
Abnormal MRI other than minor atrophy
Abnormal laboratory tests, including HIV test
Claustrophobia
Pregnancy or breast feeding. Women with child bearing potential will a pregnancy test to exclude pregnancy
Prior participation in other research protocols within the past year such that a radiation exposure together with the present study would exceed the annual limits. Limits: A total effective dose or 5.0 rem in a year.
Any condition that increases risk for MRI (e.g., pacemaker, metallic foreign body in the eye, etc.)
Traumatic brain injury, severe systemic disease, poor vision or hearing
Major medical conditions or neurological disorders
Single radial and ulnar arterial circulation. This will be determined during physical examination (A simple wrist compression test)
Individuals who recently donated blood.
Unable to lay on one's back for PET/MRI scans. PET and MRI scans take approximately 2 and 1 hours, respectively.
Novacaine allergy - yes - Local anesthetic used for insertion of arterial and venous catheters.
Positive HIV test
Study ID Numbers: | 030159, 03-M-0159 |
Study First Received: | April 16, 2003 |
Last Updated: | March 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00059046 |
Health Authority: | United States: Federal Government |
Neuroreceptors PET Measurements Kinetic Analysis |
Test/Retest Healthy Volunteer HV |
Healthy Serotonin |