Polymorphism- GeneticNCT01950377
Imaging and Genetic Investigation of Learning and Decision Making
An observational study of Polymorphism- Genetic and Reward Mediating System, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Polymorphism- Genetic, Reward Mediating System
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2014to 5 Mar 2020
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Healthy Volunteers
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
The objective of this study is to examine the effects of genetic variability in the dopamine signaling pathway on metric measures of impulsivity. Our hypothesis is that increased dopamine levels or conversion of dopamine to intracellular signals, brought about by specific variants of genes in this pathway, will increase impulsivity in our behavioral tasks. We will examine variability by recruiting up to 400 ethnically and racially diverse healthy adult male and female volunteers aged 18 to 55. We will carry out genotyping, behavioral testing and functional magnetic resonance imaging on this group. We will initially recruit a large pool of subjects for behavioral testing and genotyping. Behavioral tests will include various laboratory tasks related to impulsivity. We have recently developed a series of tasks that we have used in a group of Parkinson s patients with impulsive/compulsive behaviors (PD+ICBs). Several tasks have shown large group effects between Parkinson s patients with and without ICBs (PD +/- ICBs). We will focus on those tasks in the present study. Specific examples include information sampling tasks and measures of novelty preference. If genetic effects on behavior in the large sample are found, we will ask a subset of the original sample to return for fMRI testing. The subset will be selected to allow us to examine the neural circuits that operate differently as a function of genotype. In other words, they will be selected on the basis of their genotype. The outcome measure in this case will be differences in brain activity as a function of genotype, during performance of our behavioral task.
- Conditions
- Polymorphism- Genetic, Reward Mediating System
- Keywords
- Dopamine Transporter, D2 Dopamine Receptor Subtype, Dopamine, Dopamine Genes, Dopaminergic Mechanisms, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adults | Healthy adults healthy adults - male and female |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome measures include performance in the behavioral tasks, effects in the magnetic resonance imaging data, and the genotype of individual participants.
Outcome measures include performance in the behavioral tasks, effects in the magnetic resonance imaging data, and the genotype of individual participants.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study start11 Feb 2014
- Primary completion10 Feb 2018
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polymorphism- GeneticStudies 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
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Bruno B Averbeck, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950377
- Sponsor's protocol ID
- 130190
- Other IDs
- 13-M-0190
- Status last verified
- Jan 2022
- First submitted
- 21 Sep 2013
- Last updated
- 24 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging and Genetic Investigation of Learning and Decision Making
- ClinicalTrials.gov ID
- NCT01950377
- Acronym / sponsor ID
- 130190
- Conditions
- Polymorphism- Genetic, Reward Mediating System
- Keywords
- Dopamine Transporter, D2 Dopamine Receptor Subtype, Dopamine, Dopamine Genes, Dopaminergic Mechanisms, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 11 Feb 2014 (actual)
- Primary completion
- 10 Feb 2018 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 25 Sep 2013 (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.
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.
Detailed description
The objective of this study is to examine the effects of genetic variability in the dopamine signaling pathway on metric measures of impulsivity. Our hypothesis is that increased dopamine levels or conversion of dopamine to intracellular signals, brought about by specific variants of genes in this pathway, will increase impulsivity in our behavioral tasks. We will examine variability by recruiting up to 400 ethnically and racially diverse healthy adult male and female volunteers aged 18 to 55. We will carry out genotyping, behavioral testing and functional magnetic resonance imaging on this group. We will initially recruit a large pool of subjects for behavioral testing and genotyping. Behavioral tests will include various laboratory tasks related to impulsivity. We have recently developed a series of tasks that we have used in a group of Parkinson s patients with impulsive/compulsive behaviors (PD+ICBs). Several tasks have shown large group effects between Parkinson s patients with and without ICBs (PD +/- ICBs). We will focus on those tasks in the present study. Specific examples include information sampling tasks and measures of novelty preference. If genetic effects on behavior in the large sample are found, we will ask a subset of the original sample to return for fMRI testing. The subset will be selected to allow us to examine the neural circuits that operate differently as a function of genotype. In other words, they will be selected on the basis of their genotype. The outcome measure in this case will be differences in brain activity as a function of genotype, during performance of our behavioral task.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Adults | – | –Healthy adults healthy adults - male and female |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Healthy Volunteers
Key inclusion criteria (4 listed)
- are between 18 and 55 years of age
- are in good physical health
- speak English well enough to understand task instructions clearly
Key exclusion criteria (13 listed)
- 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.
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
Outcome measures include performance in the behavioral tasks, effects in the magnetic resonance imaging data, and the genotype of individual participants.
Time frame: ongoing
Outcome measures include performance in the behavioral tasks, effects in the magnetic resonance imaging data, and the genotype of individual participants.
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 24 Jan 2022.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Bruno B Averbeck, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
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 Polymorphism- Genetic and Reward Mediating System, 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 4 inclusion and 13 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 24 Jan 2022. 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.
What does the primary outcome measure?
Outcome measures include performance in the behavioral tasks, effects in the magnetic resonance imaging data, and the genotype of individual participants. (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2022.