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First Received Date ICMJE | April 16, 2003 |
Last Updated Date | March 3, 2008 |
Start Date ICMJE | April 2003 |
Current Primary Outcome Measures ICMJE | |
Original Primary Outcome Measures ICMJE | |
Change History | Complete list of historical versions of study NCT00059046 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE | |
Original Secondary Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Brain Imaging of Serotonin Transporters in the Brain |
Official Title ICMJE | Kinetic Studies in Whole Body and Brain of [11C]DASB PET Imaging of Serotonin Transporters |
Brief 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. |
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.
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Study Phase | |
Study Type ICMJE | Observational |
Study Design ICMJE | |
Condition ICMJE |
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Intervention ICMJE | |
Study Arms / Comparison Groups | |
Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Completed |
Enrollment ICMJE | 20 |
Completion Date | January 2005 |
Primary Completion Date | |
Eligibility Criteria ICMJE | 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 |
Gender | Both |
Ages | |
Accepts Healthy Volunteers | Yes |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID ICMJE | NCT00059046 |
Responsible Party | |
Study ID Numbers ICMJE | 030159, 03-M-0159 |
Study Sponsor ICMJE | National Institute of Mental Health (NIMH) |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | National Institutes of Health Clinical Center (CC) |
Verification Date | January 2005 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |