SchizophreniaNCT00024622
PET Scanning in Parkinson s Disease
An observational study of Schizophrenia and Parkinson's Disease, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
This is an in vivo positron emission tomography (PET) study of regional cerebral dopamine and blood flow in normal volunteers, persons with Parkinson s disease (both familial and sporadic), and those with schizophrenia spectrum disorders. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Schizophrenia, Parkinson's Disease
- What is being tested?
- O-15 Water and 18F-Fluoro-L-dopa
- How many people
- 502 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2002to not given
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is an in vivo positron emission tomography (PET) study of regional cerebral dopamine and blood flow in normal volunteers, persons with Parkinson's disease (both familial and sporadic), and those with schizophrenia spectrum disorders.
Who may be able to join
- Age between 18 and 90 years
- Ability to give informed consent
- Ability to read and write
- Ability to give adequate medical and neuropsychiatric history.
- PARKINSONS DISEASE:
- Individuals over the age of 18 from families in which an autosomal dominant form of Parkinson's disease is suspected based on pedigree analysis.
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- Each subject will have a medical history and brief neurological examination.
- The diagnosis in probands must be supported by accepted clinical criteria: tremor, bradykinesia, and responsiveness to L-DOPA.
- Equivocally affected individuals will also be included in order to aid in their phenotypic classification as will at risk individuals who show no neurological signs.
- Individuals with sporadic Parkinson's disease will also be scanned. These will be over the age of 50 years and will have no known family history of Parkinson's disease or any other movement disorder.
- PD patients will have an admission physical exam and medical history as well as laboratory tests deemed necessary on the basis of history and physical exam.
- SCHIZOPHRENIA:
- Members of this patient group will have a diagnosis of schizophrenia or schizophrenia spectrum disorder as determined by the SCID and will be currently enrolled in NIH approved protocol 89-M-0160 (Inpatient Evaluation of Neuropsychiatric Patients) under which they will have received admission work-up.
- HEALTHY VOLUNTEERS:
- A large cohort of healthy volunteers will also have a PET scan.
- Volunteers will be age, gender and handedness-matched to patients for statistical purposes.
- Volunteers, who are enrolled as healthy controls under protocol 95-M-0150 "Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and their Siblings" will receive admission workup through that protocol.
Who cannot join
- Will include medical illness that would affect cerebral blood flow or dopamine
- Current pregnancy
- Current breast feeding
- Possible exposure to radiation exceeding RSC guidelines
- History of any (excepting nicotinerelated) DSM5-defined moderate to severe substance use disorder (or DSM-IV-defined substance dependence).
- Cumulative lifetime history of any (excepting nicotine-related) DSM5-defined mild substance use disorder (or any DSM-IV-defined substance abuse),either in excess of 5 years total or not in remission for at least 6 months,
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- Inability to stay caffeine- and nicotine-free for 4 hours
- Current suicidality or assaultiveness
- History of movement disorder
- History of head injury requiring hospitalization
- History of coma
- Inability to meet general safety criteria for MRI study (as determined by standardized Nuclear Medicine Research (NMR) Center screening)
- Previously demonstrated inability or unwillingness to comply with a study protocol.
- PARKINSONS DISEASE:
- Individuals not capable of understanding the consent will be excluded.
- HEALTHY VOLUNTEERS:
- Healthy volunteers will be unable to participate if they have been treated with psychotropic medication within the three months prior to scanning, are undergoing current psychiatric treatment, have any history of major psychiatric or movement disorder, have a first degree relative with schizophrenia, or have a family history of PD.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Positron Emission Tomography (PET) Scanning in Dopamine Disorders: Parkinson's Disease and Schizophrenia
This is an in vivo positron emission tomography (PET) study of regional cerebral dopamine and blood flow in normal volunteers, persons with Parkinson s disease (both familial and sporadic), and those with schizophrenia spectrum disorders. The latter also sign consent for NIH approved protocol 89-M-0160, "Inpatient Evaluation of Neuropsychiatric Patients," PI: Daniel Eisenberg, M.D. Using PET with 6-[F-18] Fluoro-L-dopa (FDOPA) and (15)0-H2O in a single scan session, both presynaptic dopaminergic function and regional cerebral blood flow (rCBF) are assessed. The kinetic rate constant (Ki) for presynaptic dopaminergic uptake in striatum and other regions is calculated. We compare Ki across subject groups and relate the findings to rCBF. Findings are also related to allelic variation in genes of interest, for determination of which participants sign separate consent for NIH approved protocol 95-M-0150 Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings, PI: Karen F. Berman, MD. We also draw comparisons between subjects with inherited vs. sporadic Parkinson s disease to determine whether the PET phenotype is the same in both groups, and we compare system-level, circuit-based pathophysiology across PD and schizophrenia groups. Each subject is further screened with an MRI to rule out structural abnormalities and also to further delineate areas of interest in the PET scans.
Read the detailed description
This is an in vivo positron emission tomography (PET) study of regional cerebral dopamine and blood flow in normal volunteers, persons with Parkinson s disease (both familial and sporadic), and those with schizophrenia spectrum disorders. The latter also sign consent for NIH approved protocol 89-M-0160, "Inpatient Evaluation of Neuropsychiatric Patients," PI: Daniel Eisenberg, M.D. Using PET with 6-[F-18] Fluoro-L-dopa (FDOPA) and (15)0-H2O in a single scan session, both presynaptic dopaminergic function and regional cerebral blood flow (rCBF) are assessed. The kinetic rate constant (Ki) for presynaptic dopaminergic uptake in striatum and other regions is calculated. We compare Ki across subject groups and relate the findings to rCBF. Findings are also related to allelic variation in genes of interest, for determination of which participants sign separate consent for NIH approved protocol 95-M-0150 Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings, PI: Karen F. Berman, MD. We also draw comparisons between subjects with inherited vs. sporadic Parkinson s disease to determine whether the PET phenotype is the same in both groups, and we compare system-level, circuit-based pathophysiology across PD and schizophrenia groups. Each subject is further screened with an MRI to rule out structural abnormalities and also to further delineate areas of interest in the PET scans.
- Conditions
- Schizophrenia, Parkinson's Disease
- Being tested
- O-15 Water, 18F-Fluoro-L-dopa
- Keywords
- Neurological Disorder, Regional Cerebral Blood Flow, Dopamine, Schizophrenia, Parkinson's Disease, Natural History, PD, Parkinson, Healthy Control, HV, Normal Control
- Medical subject headings
- Schizophrenia, Parkinson Disease, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O-15 WaterDrug
O-15 Water
18F-Fluoro-L-dopaDrug
18F-Fluoro-L-dopa
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Healthy volunteers. Receives: Drug: O-15 Water | |
| Patients - Parkinsons | Patients with Parkinsons Receives: Drug: O-15 Water; Drug: 18F-Fluoro-L-dopa | |
| Patients - schizophrenia spectrum disorders | Patients - schizophrenia spectrum disorders Receives: Drug: O-15 Water; Drug: 18F-Fluoro-L-dopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore with positron emission tomography (PET) the pathophysiology and cerebral consequences of dopaminergic dysregulation.
To explore with positron emission tomography (PET) the pathophysiology and cerebral consequences of dopaminergic dysregulation.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2001 (estimated)
- Study start15 Mar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Karen F Berman, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00024622
- Sponsor's protocol ID
- 010232
- Other IDs
- 01-M-0232
- Status last verified
- 1 Oct 2026
- First submitted
- 23 Sep 2001
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Eisenberg DP, Blackman RK, Tietcheu MG, Kohn PD, Bettina JS, Kolachana B, Gregory MD, Berman KF. Genetic risk for treatment resistant schizophrenia and corresponding variation in dopamine synthesis capacity and D2/3 receptor availability in healthy individuals. Mol Psychiatry. 2025 Jun;30(6):2645-2652. doi: 10.1038/s41380-024-02873-2. Epub 2024 Dec 27.
PubMed 39730881Ianni AM, Eisenberg DP, Boorman ED, Constantino SM, Hegarty CE, Gregory MD, Masdeu JC, Kohn PD, Behrens TE, Berman KF. PET-measured human dopamine synthesis capacity and receptor availability predict trading rewards and time-costs during foraging. Nat Commun. 2023 Sep 30;14(1):6122. doi: 10.1038/s41467-023-41897-0.
PubMed 37777515Eisenberg DP, Kohn PD, Hegarty CE, Smith NR, Grogans SE, Czarapata JB, Gregory MD, Apud JA, Berman KF. Clinical correlation but no elevation of striatal dopamine synthesis capacity in two independent cohorts of medication-free individuals with schizophrenia. Mol Psychiatry. 2022 Feb;27(2):1241-1247. doi: 10.1038/s41380-021-01337-1. Epub 2021 Nov 17.
PubMed 34789848Eisenberg DP, Kohn PD, Hegarty CE, Ianni AM, Kolachana B, Gregory MD, Masdeu JC, Berman KF. Common Variation in the DOPA Decarboxylase (DDC) Gene and Human Striatal DDC Activity In Vivo. Neuropsychopharmacology. 2016 Aug;41(9):2303-8. doi: 10.1038/npp.2016.31. Epub 2016 Feb 29.
PubMed 26924680
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography (PET) Scanning in Dopamine Disorders: Parkinson's Disease and Schizophrenia
- ClinicalTrials.gov ID
- NCT00024622
- Acronym / sponsor ID
- 010232
- Conditions
- Schizophrenia, Parkinson's Disease
- Keywords
- Neurological Disorder, Regional Cerebral Blood Flow, Dopamine, Schizophrenia, Parkinson's Disease, Natural History, PD, Parkinson
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 15 Mar 2002 (actual)
- First posted
- 24 Sep 2001 (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.
This is an in vivo positron emission tomography (PET) study of regional cerebral dopamine and blood flow in normal volunteers, persons with Parkinson s disease (both familial and sporadic), and those with schizophrenia spectrum disorders. The latter also sign consent for NIH approved protocol 89-M-0160, "Inpatient Evaluation of Neuropsychiatric Patients," PI: Daniel Eisenberg, M.D. Using PET with 6-[F-18] Fluoro-L-dopa (FDOPA) and (15)0-H2O in a single scan session, both presynaptic dopaminergic function and regional cerebral blood flow (rCBF) are assessed. The kinetic rate constant (Ki) for presynaptic dopaminergic uptake in striatum and other regions is calculated. We compare Ki across subject groups and relate the findings to rCBF. Findings are also related to allelic variation in genes of interest, for determination of which participants sign separate consent for NIH approved protocol 95-M-0150 Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings, PI: Karen F. Berman, MD. We also draw comparisons between subjects with inherited vs. sporadic Parkinson s disease to determine whether the PET phenotype is the same in both groups, and we compare system-level, circuit-based pathophysiology across PD and schizophrenia groups. Each subject is further screened with an MRI to rule out structural abnormalities and also to further delineate areas of interest in the PET scans.
Detailed description
This is an in vivo positron emission tomography (PET) study of regional cerebral dopamine and blood flow in normal volunteers, persons with Parkinson s disease (both familial and sporadic), and those with schizophrenia spectrum disorders. The latter also sign consent for NIH approved protocol 89-M-0160, "Inpatient Evaluation of Neuropsychiatric Patients," PI: Daniel Eisenberg, M.D. Using PET with 6-[F-18] Fluoro-L-dopa (FDOPA) and (15)0-H2O in a single scan session, both presynaptic dopaminergic function and regional cerebral blood flow (rCBF) are assessed. The kinetic rate constant (Ki) for presynaptic dopaminergic uptake in striatum and other regions is calculated. We compare Ki across subject groups and relate the findings to rCBF. Findings are also related to allelic variation in genes of interest, for determination of which participants sign separate consent for NIH approved protocol 95-M-0150 Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings, PI: Karen F. Berman, MD. We also draw comparisons between subjects with inherited vs. sporadic Parkinson s disease to determine whether the PET phenotype is the same in both groups, and we compare system-level, circuit-based pathophysiology across PD and schizophrenia groups. Each subject is further screened with an MRI to rule out structural abnormalities and also to further delineate areas of interest in the PET scans.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Drug: O-15 WaterHealthy volunteers. |
| Patients - Parkinsons | – | Drug: O-15 Water, Drug: 18F-Fluoro-L-dopaPatients with Parkinsons |
| Patients - schizophrenia spectrum disorders | – | Drug: O-15 Water, Drug: 18F-Fluoro-L-dopaPatients - schizophrenia spectrum disorders |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is an in vivo positron emission tomography (PET) study of regional cerebral dopamine and blood flow in normal volunteers, persons with Parkinson's disease (both familial and sporadic), and those with schizophrenia spectrum disorders.
Key inclusion criteria (17 listed)
- Age between 18 and 90 years
- Ability to give informed consent
- Ability to read and write
- Ability to give adequate medical and neuropsychiatric history.
- Individuals over the age of 18 from families in which an autosomal dominant form of Parkinson's disease is suspected based on pedigree analysis.
Key exclusion criteria (17 listed)
- Will include medical illness that would affect cerebral blood flow or dopamine
- Current pregnancy
- Current breast feeding
- Possible exposure to radiation exceeding RSC guidelines
- History of any (excepting nicotinerelated) DSM5-defined moderate to severe substance use disorder (or DSM-IV-defined substance dependence).
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 |
|---|---|---|
| O-15 WaterO-15 Water | Drug | Healthy volunteers, Patients - Parkinsons, Patients - schizophrenia spectrum disorders |
| 18F-Fluoro-L-dopa18F-Fluoro-L-dopa | Drug | Patients - Parkinsons, Patients - schizophrenia spectrum disorders |
Primary outcome
To explore with positron emission tomography (PET) the pathophysiology and cerebral consequences of dopaminergic dysregulation.
Time frame: Ongoing
To explore with positron emission tomography (PET) the pathophysiology and cerebral consequences of dopaminergic dysregulation.
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 5 Nov 2026.
- Derived from this study: PubMed 39730881Eisenberg DP, Blackman RK, Tietcheu MG, Kohn PD, Bettina JS, Kolachana B, Gregory MD, Berman KF. Genetic risk for treatment resistant schizophrenia and corresponding variation in dopamine synthesis capacity and D2/3 receptor availability in healthy individuals. Mol Psychiatry. 2025 Jun;30(6):2645-2652. doi: 10.1038/s41380-024-02873-2. Epub 2024 Dec 27.
- Derived from this study: PubMed 37777515Ianni AM, Eisenberg DP, Boorman ED, Constantino SM, Hegarty CE, Gregory MD, Masdeu JC, Kohn PD, Behrens TE, Berman KF. PET-measured human dopamine synthesis capacity and receptor availability predict trading rewards and time-costs during foraging. Nat Commun. 2023 Sep 30;14(1):6122. doi: 10.1038/s41467-023-41897-0.
- Derived from this study: PubMed 34789848Eisenberg DP, Kohn PD, Hegarty CE, Smith NR, Grogans SE, Czarapata JB, Gregory MD, Apud JA, Berman KF. Clinical correlation but no elevation of striatal dopamine synthesis capacity in two independent cohorts of medication-free individuals with schizophrenia. Mol Psychiatry. 2022 Feb;27(2):1241-1247. doi: 10.1038/s41380-021-01337-1. Epub 2021 Nov 17.
- Derived from this study: PubMed 26924680Eisenberg DP, Kohn PD, Hegarty CE, Ianni AM, Kolachana B, Gregory MD, Masdeu JC, Berman KF. Common Variation in the DOPA Decarboxylase (DDC) Gene and Human Striatal DDC Activity In Vivo. Neuropsychopharmacology. 2016 Aug;41(9):2303-8. doi: 10.1038/npp.2016.31. Epub 2016 Feb 29.
- 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.
Karen F Berman, M.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 Schizophrenia and Parkinson's Disease, 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 17 inclusion and 17 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 5 Nov 2026. 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?
To explore with positron emission tomography (PET) the pathophysiology and cerebral consequences of dopaminergic dysregulation. (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00024622, which also lists 4 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 5 Nov 2026.