HealthyPhase 2NCT00062946
PET Imaging of Dopamine in Healthy Study Participants
A Phase 2 study testing (18F)fallypride in people with Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
The purpose of this study is to measure molecules on or in cells that interact with a chemical in the nervous system, called dopamine. Investigators will obtain two kinds of images of the brain-a position emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- (18F)fallypride
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2003to 15 Aug 2007
- Phase
- Phase 2
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-45, inclusive
- In good general health on basis of history and physical examination
- Normal screening laboratory studies including thyroid function tests, blood count, serum electrolytes, liver and kidney function, and urinalysis
- Normal ECG at a resting condition
- Normal blood pressure
- No illegal drug use based on urine drug screen
Who cannot join
- Pregnancy/Nursing
- Evidence of active mental or neurological illness
- Medically significant biochemical or hematological abnormality on screening laboratory studies
- Abnormal ECG
- High Blood Pressure (above 140 systolic and/or above 90 dystolic pressure)
- History of myocardial infarction or angina pectoris
Show all 11Show fewer
- Positive urine drug screen or use of alcohol within one week prior to each PET study
- History of substance abuse or dependence within 6 months
- Presence of ferromagnetic metal in the body or heart pacemaker
- Body weight more than 93 kg to limit AMPT dose to 4 g/ day (only for subjects having four PET scans and d-amphetamine and AMPT administration)
- Claustrophobia
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
Official title: PET Imaging of Dopamine D2 Receptors and Extracellular Dopamine With (18F)Fallypride, D-amphetamine, and Alpha-Methyl-Para-Tyrosine in Healthy Subjects
The purpose of this study is to measure molecules on or in cells that interact with a chemical in the nervous system, called dopamine. Investigators will obtain two kinds of images of the brain-a position emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan.
Thirty-eight participants aged 18 to 45 will be enrolled in this study. They must have no history of medical or psychiatric illness, including substance abuse. Participants will have four appointments at NIH. On the first visit, they will undergo a physical exam, a medical history, and lab tests. The second and third visits will involve PET scans and the fourth visit will involve an MRI scan.
Participants will be compensated up to $430 for their involvement in this study.
Read the detailed description
Abnormalities of dopaminergic function have been implicated in a number of neurological and psychiatric illnesses, including Parkinson's disease, schizophrenia, and psychostimulant dependence syndromes. Functional imaging with positron emission tomography (PET) and single photon emission computed tomography (SPECT) have demonstrated the feasibility of in vivo measurement of the distribution and the density of dopamine (DA) D1 and D2 receptors in humans. Besides simple measurement of receptor density, it has been shown that the competition between endogenous neurotransmitters and radiolabeled tracers might provide a tool to estimate extracellular levels of neurotransmitters. However, most of those studies have been confined to the striatum. In this protocol using a PET tracer (18F)fallypride, we will estimate both stimulant-induced DA release and baseline DA levels in the striatum and extrastriatal regions by comparing baseline scans and those after d-amphetamine or alpha-methyl-para-tryosine (AMPT) adminstration. In addition, to explore genetic factors that determine synaptic DA levels, allelic variations of two genes that regulate DA levels, catechol-O-methyltransferase and dopamine transporter, will be studied.
A recent study showed that oral administration of d-amphetamine induced displacement of (11C) raclopride in a similar way as the commonly used method of i.v. administration. The current protocol will be performed in two steps. First, the method of d-amphetamine administration will be determined by studying effects of oral d-amphetamine on the binding of (18F) fallypride binding. If oral administration effectively displaces the radioligand binding, this method will be applied in the subsequent study of examining effects of each of d-amphetamine and AMPT in individual subjects.
If this study successfully detects the influence of DA levels on (18F)fallypride binding, the same design will be applied to the studies of patients with psychiatric and neurological disorders.
- Conditions
- Healthy
- Being tested
- (18F)fallypride
- Keywords
- Thalamus, Cerebral Cortices, Quantification, Reproducibility, Dopamine Release, (18F) Fallypride, D-Amphetamine, Alpha-Methyl-Para-Tyrosine (AMPT), PET, Dopamine D2 Receptor, Healthy Volunteer, HV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(18F)fallyprideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2003 (estimated)
- Study start17 Jun 2003
- Study completion15 Aug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 45 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
- NCT00062946
- Sponsor's protocol ID
- 030104
- Other IDs
- 03-M-0104
- Status last verified
- 15 Aug 2007
- First submitted
- 17 Jun 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Anand A, Verhoeff P, Seneca N, Zoghbi SS, Seibyl JP, Charney DS, Innis RB. Brain SPECT imaging of amphetamine-induced dopamine release in euthymic bipolar disorder patients. Am J Psychiatry. 2000 Jul;157(7):1108-14. doi: 10.1176/appi.ajp.157.7.1108.
PubMed 10873919
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging of Dopamine D2 Receptors and Extracellular Dopamine With (18F)Fallypride, D-amphetamine, and Alpha-Methyl-Para-Tyrosine in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00062946
- Acronym / sponsor ID
- 030104
- Conditions
- Healthy
- Keywords
- Thalamus, Cerebral Cortices, Quantification, Reproducibility, Dopamine Release, (18F) Fallypride, D-Amphetamine, Alpha-Methyl-Para-Tyrosine (AMPT)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 17 Jun 2003
- Study completion
- 15 Aug 2007
- First posted
- 18 Jun 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.
The purpose of this study is to measure molecules on or in cells that interact with a chemical in the nervous system, called dopamine. Investigators will obtain two kinds of images of the brain-a position emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan.
Thirty-eight participants aged 18 to 45 will be enrolled in this study. They must have no history of medical or psychiatric illness, including substance abuse. Participants will have four appointments at NIH. On the first visit, they will undergo a physical exam, a medical history, and lab tests. The second and third visits will involve PET scans and the fourth visit will involve an MRI scan.
Participants will be compensated up to $430 for their involvement in this study.
Detailed description
Abnormalities of dopaminergic function have been implicated in a number of neurological and psychiatric illnesses, including Parkinson's disease, schizophrenia, and psychostimulant dependence syndromes. Functional imaging with positron emission tomography (PET) and single photon emission computed tomography (SPECT) have demonstrated the feasibility of in vivo measurement of the distribution and the density of dopamine (DA) D1 and D2 receptors in humans. Besides simple measurement of receptor density, it has been shown that the competition between endogenous neurotransmitters and radiolabeled tracers might provide a tool to estimate extracellular levels of neurotransmitters. However, most of those studies have been confined to the striatum. In this protocol using a PET tracer (18F)fallypride, we will estimate both stimulant-induced DA release and baseline DA levels in the striatum and extrastriatal regions by comparing baseline scans and those after d-amphetamine or alpha-methyl-para-tryosine (AMPT) adminstration. In addition, to explore genetic factors that determine synaptic DA levels, allelic variations of two genes that regulate DA levels, catechol-O-methyltransferase and dopamine transporter, will be studied.
A recent study showed that oral administration of d-amphetamine induced displacement of (11C) raclopride in a similar way as the commonly used method of i.v. administration. The current protocol will be performed in two steps. First, the method of d-amphetamine administration will be determined by studying effects of oral d-amphetamine on the binding of (18F) fallypride binding. If oral administration effectively displaces the radioligand binding, this method will be applied in the subsequent study of examining effects of each of d-amphetamine and AMPT in individual subjects.
If this study successfully detects the influence of DA levels on (18F)fallypride binding, the same design will be applied to the studies of patients with psychiatric and neurological disorders.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-45, inclusive
- In good general health on basis of history and physical examination
- Normal screening laboratory studies including thyroid function tests, blood count, serum electrolytes, liver and kidney function, and urinalysis
- Normal ECG at a resting condition
- Normal blood pressure
Key exclusion criteria (11 listed)
- Pregnancy/Nursing
- Evidence of active mental or neurological illness
- Medically significant biochemical or hematological abnormality on screening laboratory studies
- Abnormal ECG
- High Blood Pressure (above 140 systolic and/or above 90 dystolic pressure)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (18F)fallypride | Drug | – |
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 2 Jul 2017.
- Background: PubMed 10873919Anand A, Verhoeff P, Seneca N, Zoghbi SS, Seibyl JP, Charney DS, Innis RB. Brain SPECT imaging of amphetamine-induced dopamine release in euthymic bipolar disorder patients. Am J Psychiatry. 2000 Jul;157(7):1108-14. doi: 10.1176/appi.ajp.157.7.1108.
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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?
A Phase 2 study testing (18F)fallypride in people with Healthy, 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 6 inclusion and 11 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 2 Jul 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 NCT00062946, which also lists 1 linked publication.
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 2 Jul 2017.