- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00059046
Brain Imaging of Serotonin Transporters in the Brain
Kinetic Studies in Whole Body and Brain of [11C]DASB PET Imaging of Serotonin Transporters
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.
Study Overview
Status
Conditions
Detailed Description
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.
- The NIH RDRC (Radioactive Drug Research Committee) review of this protocol asked that we obtain human biodistribution data to confirm the expected low levels of radiation exposure, based upon our prior studies in monkeys.
- To address one of the criticisms raised by the CSRP review, namely 1) to quantify SERT binding parameters with [11C]DASB in up to 10 normal subjects and 2) to determine the reliability and reproducibility of SERT binding parameter measurements by performing a second retest [11C]DASB PET study in the same subjects, because such data are not available for this radioligand. PET scanning will be performed with an intravenous injection of 20 mCi of [11C]DASB for 2 h, during which multiple arterial blood samples will also be obtained. The reproducibility of SERT binding parameters will be assessed by calculating the variability as well as the intraclass correlation coefficient between test/retest measurements. We expect that 1) we can accurately quantify SERT binding parameters using [11C]DASB PET imaging and 2) [11C]DASB PET measurements of SERT binding will be reliable and reproducible.
Study Type
Enrollment
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institute of Mental Health (NIMH)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- 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. doi: 10.1016/0014-2999(85)90473-x.
- 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. doi: 10.1212/wnl.36.4.556.
- 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. doi: 10.1016/0028-3908(84)90100-x.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 030159
- 03-M-0159
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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