AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in United States

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.

  1. 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.
  2. 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.
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.

  1. First posted16 Apr 2003 (estimated)
  2. Study startApr 2003
  3. Study completionJan 2005

Resources

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
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 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. doi: 10.1212/wnl.36.4.556.

    PubMed 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. doi: 10.1016/0028-3908(84)90100-x.

    PubMed 6084823

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 uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in