Neuroimaging of Dopamine Metabolism in Normal and Psychiatric Patients (NCT00001320) | Clinical Trial Compass
CompletedNot Applicable
Neuroimaging of Dopamine Metabolism in Normal and Psychiatric Patients
United States265 participantsStarted 1991-10
Plain-language summary
Brain cells communicate with each other by releasing chemicals called neurotransmitters. In order for brain cells to transfer information, one cell will release a neurotransmitter that will be recognized by a receptor located on surface of another cell. One such neurotransmitter is dopamine.
Abnormal dopamine transmission has been seen in patients with substance abuse and different neuropsychiatric disorders including schizophrenia.
A radioactive drug called IZBM (I-123 iodobenzamide) can also bind to certain dopamine receptors. IZBM can be seen by Single Photon Emission Tomography (SPECT). Therefore, by using IZBM and SPECT scans, researchers can find and "map" the location of dopamine receptors in the brain.
Patients participating in this study must also have been selected for other genetic studies being conducted at the NIMH. Patients with schizophrenia will be selected from a NIMH research study titled, "Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings" (95-M-0150). Normal patient volunteers will be selected from another NIMH study titled, "Inpatient Evaluation of Neuropsychiatric Patients" (89-M-0160). All aspects of clinical care and genetic analysis of these patients will be covered in these studies, while information pertaining to IBZM SPECT scans will be covered in this study.
This study will not directly benefit patients participating in it. However, information gathered may contribute to faster and more accurate diagnosis of schizophrenia and eventually better treatment for the disorder.
Who can participate
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA:
Patients with schizophrenia will be recruited exclusively from among inpatients who are participating in clinical studies of the Clinical Brain Disorders Branch of NIMH under NIH protocol #89-M-0160 (Egan 1999a) and for whom genetic data is already available.
Normal volunteers will be recruited exclusively from among individuals who have volunteered for studies under NIH protocol #95-M-0150 (Egan 1999b) as normal control subjects and for whom genetic data is already being analyzed.
EXCLUSION CRITERIA:
Pregnancy: All women of childbearing age must undergo a pregnancy test prior to injection or radioactive isotope. If the pregnancy test is positive or if the woman has reason to believe she might be pregnant, she will be excluded from this study.
Breastfeeding: Women who are breastfeeding will be excluded from this study to avoid unwarranted risk to their children.
Iodine sensitivity: Subjects with a prior reaction to iodine, iodine compounds, or shellfish will be excluded from this study. Also, subjects with a history of thyroid disease or dysfunction will be excluded from this study.
Substance abuse: Subjects with a history of recent substance abuse will be excluded from this study.
Metal objects in body: Subjects with metal objects in their bodies as specified in our MRI protocol (91-M-0124) will be excluded from this study.
INCLUSION CRITERIA FOR PATIENTS WITH SCHIZOPHRENIA:
Prior participation as a NIMH inpatient under NIH protocol #89-M-0160.
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.