Protocol Number: 03-M-0159

Title:

Kinetic Studies in Whole Body and Brain of [11C]DASB PET Imaging of Serotonin Transporters

Number:

03-M-0159

Summary:

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.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

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

Special Instructions: Currently Not Provided

Keywords:

Neuroreceptors

PET Measurements

Kinetic Analysis

Test/Retest

Recruitment Keywords:

Healthy Volunteer

HV

Conditions:

Healthy

Serotonin Transporter

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Cash R, Raisman R, Ploska A, Agid Y. High and low affinity [3H]imipramine binding sites in control and parkinsonian brains.

Eur J Pharmacol. 1985 Oct 29;117(1):71-80. PMID: 3002804

Raisman R, Cash R, Agid Y. Parkinson's disease: decreased density of 3H-imipramine and 3H-paroxetine binding sites in putamen. Neurology. 1986 Apr;36(4):556-60. PMID: 2938025

Crow TJ, Cross AJ, Cooper SJ, Deakin JF, Ferrier IN, Johnson JA, Joseph MH, Owen F, Poulter M, Lofthouse R, et al. Neurotransmitter receptors and monoamine metabolites in the brains of patients with Alzheimer-type dementia and depression, and suicides. Neuropharmacology. 1984 Dec;23(12B):1561-9.

PMID: 6084823

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