HealthyNCT00059046
Brain Imaging of Serotonin Transporters in the Brain
An observational study of Healthy and Serotonin Transporter, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy, Serotonin Transporter
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Jan 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Diagnosis: Healthy
- Ages: 18-50 years
- Age: 18-50 y
- Male or female
- Consent given
Who cannot join
- 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
Show all 23Show fewer
- Positive HIV test
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy, Serotonin Transporter
- Keywords
- Neuroreceptors, PET Measurements, Kinetic Analysis, Test/Retest, Healthy Volunteer, HV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2003 (estimated)
- Study startApr 2003
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059046
- Sponsor's protocol ID
- 030159
- Other IDs
- 03-M-0159
- Status last verified
- Jan 2005
- First submitted
- 16 Apr 2003
- Last updated
- 4 Mar 2008
- Results posted
- No
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.
PubMed 3002804Raisman 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.
PubMed 2938025Crow 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.
PubMed 6084823
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetic Studies in Whole Body and Brain of [11C]DASB PET Imaging of Serotonin Transporters
- ClinicalTrials.gov ID
- NCT00059046
- Acronym / sponsor ID
- 030159
- Conditions
- Healthy, Serotonin Transporter
- Keywords
- Neuroreceptors, PET Measurements, Kinetic Analysis, Test/Retest, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Apr 2003
- Study completion
- Jan 2005
- First posted
- 16 Apr 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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 design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis: Healthy
- Ages: 18-50 years
- Age: 18-50 y
- Male or female
- Consent given
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 3002804Cash 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.
- Background: PubMed 2938025Raisman 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.
- Background: PubMed 6084823Crow 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Serotonin Transporter, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00059046, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008; AzTrials last refreshed its copy on 8 Nov 2026.