- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01950377
Imaging and Genetic Investigation of Learning and Decision Making
Background:
- Previous research has shown that dopamine, a brain chemical, is involved in decision making. Different genes influence how much dopamine people have in their brains and how that affects their behavior. Researchers will study if genes associated with dopamine affect decision making and impulsiveness. All participants will take tests; some will have brain images taken. Researchers will study the test responses and images; they will look for how differences in these genes affect different types of decision making.
Objectives:
- To see if genes involved in a brain chemical, dopamine, are related to impulsiveness on behavioral tests.
Eligibility:
- Healthy adults ages 18 to 55.
Design:
- Participants will be screened with a medical history and physical exam.
- All participants in this study will have at least 1 outpatient visit to the NIH Clinical Center. Each visit will last 2 4 hours. At the first visit:
- A blood sample will be taken only from participants that have not been previously enrolled in 95-M-0150
- Participants will be given tests of their memory, attention, concentration, and thinking.
- Some participants will have a second visit. It will be scheduled as soon as possible after the first. At the second visit:
- Participants will have an MRI (magnetic resonance imaging). They will have to lie in a scanner for up to 2 hours. The MRI uses magnets, radio waves, and computers to produce detailed pictures of the brain.
- Participants will repeat the tests from the first visit. Some will be done during the MRI.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
Subjects will be eligible for this study if they:
- are between 18 and 55 years of age
- are in good physical health
- speak English well enough to understand task instructions clearly
EXCLUSION CRITERIA:
Subjects will not be eligible for this study if they:
- have a major medical (e.g. heart disease), neurological (e.g. stroke) or psychiatric (e.g. bipolar disorder) illness
- have a vision and/or hearing problem that interferes with testing
- currently use any psychotropic medication, antidepressants, steroids or opiates
- currently use alcohol in excess of 14 drinks/week for males or 7 drinks/week for females.
- have a lifetime history of or currently have alcohol or substance use or dependence (excluding nicotine) that requires independent, concurrent treatment intervention (such as, antabuse or opiate treatment). This does not include self-help group treatment/intervention.
- cannot understand the consent and procedures or cannot consent themselves to the study
- Smoke more than a half pack of cigarettes a day
- NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy.
In addition to the above, additional exclusion criteria apply for all MRI studies:
- Female subjects who are pregnant or have a positive pregnancy test 24 hours prior to an experiment will be excluded from neuroimaging studies.
- All subjects will be questioned prior to MRI scanning for possible occupational exposure to metal slivers or shavings, which may have become accidentally lodged in the tissues of the head or neck. Subjects with surgical clips or shrapnel in or near the brain or blood vessels, subjects with cochlear implants, subjects with any metallic body in the eye or CNS, and subjects with any form of implant wire or metal device which may concentrate radiofrequency fields will be excluded from MRI scanning experiments because of possible risks during MRI scanning. Those whose history is suggestive of such a problem will also be excluded from the MRI portion of the experiments. They may still participate in the behavioral experiments.
- Subjects unable to lie flat on their back for up to 2 hours or who are uncomfortable in small close spaces (have claustrophobia) will not be eligible to participate in MRI scans.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healthy Adults
Healthy adults healthy adults - male and female
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Outcome measures include performance in the behavioral tasks, effects in the magnetic resonance imaging data, and the genotype of individual participants.
Time Frame: ongoing
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Outcome measures include performance in the behavioral tasks, effects in the magnetic resonance imaging data, and the genotype of individual participants.
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ongoing
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Collaborators and Investigators
Investigators
- Principal Investigator: Bruno B Averbeck, Ph.D., National Institute of Mental Health (NIMH)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 130190
- 13-M-0190
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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