Functional Relevance of Dopamine Receptors in Healthy Controls and Patients With Schizophrenia: Characterization Through [11C]NNC-112 and [18F]Fallypride Positron Emission Tomography
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| ClinicalTrials.gov Identifier: NCT00942981 |
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Recruitment Status :
Recruiting
First Posted : July 21, 2009
Last Update Posted : September 19, 2018
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Sponsor:
National Institute of Mental Health (NIMH)
Information provided by:
National Institutes of Health Clinical Center (CC)
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Brief Summary:
Background:
- Some illnesses, such as schizophrenia, have effects on brain cells called dopamine receptors, which are required for normal brain function. People with schizophrenia have difficulty thinking and experience hallucinations and delusions. Medications that change brain dopamine receptors can decrease these hallucinations and delusions.
- The cause of schizophrenia and its association with brain dopamine receptors is not known but may be clarified by studying dopamine receptors in people who have dopamine disorders (such as schizophrenia) and those who do not. Researchers are interested in studying the dopamine system to gain a better idea of how dopamine disorders develop, which may lead to better medical care for people with schizophrenia.
Objectives:
- To study the amount and distribution of two types of dopamine receptors.
Eligibility:
- Individuals between the ages of 18 and 60 who have schizophrenia.
- Healthy volunteers between the ages of 18 and 90.
Design:
- Participants will undergo a full screening, with physical and psychological history, a neurological examination, and blood and urine samples.
- Participants will have a blood flow map of the brain recorded with a positron emission tomography (PET) brain scan. A magnetic resonance imaging (MRI) scan will also be performed to determine brain anatomy.
- To study the amount and distribution of dopamine receptors in the brain, participants will receive a small amount of a radioactive chemical in the vein, followed by a PET scan.
- The procedure will be performed twice in two separate sessions, once for [18F]fallypride and once for [11C]NNC-112.
| Condition or disease |
|---|
| Schizoaffective Disorder Schizophrenia |
Show Detailed Description
| Study Type : | Observational |
| Estimated Enrollment : | 330 participants |
| Time Perspective: | Other |
| Official Title: | Functional Relevance of Dopamine Receptors in Healthy Controls and Patients With Schizophrenia: Characterization Through [11C]NNC-112 and [18F]Fallypride Positron Emission Tomography |
| Study Start Date : | July 17, 2009 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Schizophrenia
Primary Outcome Measures :
- Regional binding potentials of [11C]NNC-112 and [18F]Fallypride
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
- INCLUSION CRITERIA:
- Subjects will be recruited among individuals volunteering for NIH protocol 95-M-0150 A Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings (PI: Daniel Weinberger, M.D.), NIH protocol 00-M-0085 Structural and Functional Imaging of Neuropsychiatric Patients and Normal Volunteers with 3.0 Tesla MRI and Magnetoencephalography. (P.I.: Venkata Mattay, MD) or NIH protocol 89-M-0160 Inpatient Evaluation of Neuropsychiatric Patients (PI: Jose Apud, M.D. Ph.D).
- Only adult subjects who are able to provide informed consent will be studied.
- Patients will be between 18 and 60 years of age. Healthy controls will be matched by age and sex to the patients.
- Control subjects must be healthy based on history, laboratory and physical exam obtained through the above mentioned protocols and will be included up to the age of 90 years.
EXCLUSION CRITERIA: (for patients and controls except where indicated)
- Subjects will be excluded if they don t fit the study requirements regarding age, ability to provide informed consent, absence of significant general medical, neurological or psychiatric disorders (except the disorder object of study), or intake of substances that interfere with central dopaminergic signaling.
- Pregnant or breast feeding.
- Current psychiatric illness except for patients with schizophrenia, schizoaffective disorder or other psychotic disorder
- Current or prior use (within 4 weeks) of substances that interfere with central dopaminergic signaling (e.g. antipsychotics, dopamine receptor agonists, anticholinergics, MAO-B inhibitors)
- History of any (excepting nicotine- related) DSM5-defined substance dependence).
- Cumulative lifetime history of any (excepting nicotine -related) DSM5-defined mild substance use disorder (or any DSM-IV-defined substance abuse
- Controls with current psychiatric illness other than schizophrenia, schizoaffective disorder, or other psychotic disorder
- Secondary causes of schizophrenia-like syndromes, e.g. amphetamine abuse, brain infarction, tumor, or trauma
- Neurological disorders except those of exclusively peripheral location
- Significant prior or current substance abuse, severe systemic disease, hypothyroidism not compensated by medication
- Laboratory tests with clinically significant abnormalities
- History of a significantly abnormal EEG, cranial CT or MRI
- Conditions that increase risk for MRI (pacemaker devices, ferromagnetic metal implants, etc.)
- Prior participation in other research protocols such that radiation exposure would exceed the annual NIH RSC limits
- Any medical condition that, in the opinion of the investigators, would interfere with the safe conduct of the study.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942981
Contacts
| Contact: Jasmin Czarapata, Ph.D. | (301) 435-7645 | js733c@nih.gov | |
| Contact: Karen F Berman, M.D. | (301) 496-7603 | bermank@mail.nih.gov |
Locations
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 prpl@cc.nih.gov | |
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
| Principal Investigator: | Karen F Berman, M.D. | National Institute of Mental Health (NIMH) |
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00942981 History of Changes |
| Other Study ID Numbers: |
090176 09-M-0176 |
| First Posted: | July 21, 2009 Key Record Dates |
| Last Update Posted: | September 19, 2018 |
| Last Verified: | September 17, 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No | |
Keywords provided by National Institutes of Health Clinical Center (CC):
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PET Study (18F) Fallypride (11C)NNC-112 Schizoaffective Disorder |
Schizophrenia Healthy Volunteer HV |
Additional relevant MeSH terms:
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Schizophrenia Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Dopamine Cardiotonic Agents Sympathomimetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Protective Agents |