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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 3, 1999 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | May 1998 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00001771 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | I-123 Brain Studies of Serotonin Metabolism in Psychiatric Patients and Normal Volunteers |
| Official Title ICMJE | I-123 Beta-CIT SPECT Studies of Dopamine and Serotonin Transporters in Neuropsychiatric Patients and Normal Volunteers |
| Brief Summary | Abnormalities in the re-uptake of dopamine and serotonin have been described in various neuropsychiatric disorders and substance abuse. [I-123] Beta-CIT is a recently developed radioligand for SPECT imaging of dopamine and serotonin transporters. [I-123]Beta-CIT SPECT has been used at the SPECT-lab of the Clinical Brain Disorders Branch in over fifty subjects without adverse events. Due to the trace concentrations used, a pharmacological effect of Beta-CIT is unlikely and has not been observed. The purpose of this study is to use Beta-CIT and SPECT to study the expression of dopamine and serotonin transporters in vivo in normal controls and various patient populations to address hypothesized abnormalities of the transporters in different disorders and to understand the effects of genetic variations in the genes of these transporters on their in vivo expression. |
| Detailed Description | Abnormalities in the re-uptake of dopamine and serotonin have been described in various neuropsychiatric disorders and substance abuse. [I-123] Beta-CIT is a recently developed radioligand for SPECT imaging of dopamine and serotonin transporters. [I-123]Beta-CIT SPECT has been used at the SPECT-Lab of the Clinical Brain Disorders Branch in over fifty subjects without adverse events. Due to the trace concentrations used, a pharmacological effect of Beta-CIT is unlikely and has not been observed. The purpose of this study is to use Beta-CIT and SPECT to study the expression of dopamine and serotonin transporters in vivo in normal controls and various patient populations to address hypothesized abnormalities of the transporters in different disorders and to understand the effects of genetic variations in the genes of these transporters on their in vivo expression. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 112 |
| Completion Date | May 2003 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | INCLUSION CRITERIA: No Axis I or Axis II diagnoses. EXCLUSION CRITERIA FOR ALL SUBJECTS: 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. Women who are breastfeeding will be excluded from this study to avoid unwarranted risk to their children. Subjects with a prior reaction to iodine, iodine compounds, or shellfish will be excluded from this study. Subjects with a history of thyroid disease or dysfunction will be excluded from this study. Subjects with a history of recent substance abuse will be excluded from this study. Subjects with metal objects in their bodies as specified in our MRI protocol (91-M-0124) will be excluded from this study. If a structural abnormality of the brain is detected on MRI, subjects will be excluded from the study. EXCLUSION CRITERIA FOR NORMAL CONTROLS: Subjects with an Axis I or Axis II disorder will be excluded. Subjects with concomitant medical or neurological disorders which require ongoing medication, or which may affect the central nervous system will be excluded. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00001771 |
| Responsible Party | |
| Study ID Numbers ICMJE | 980094, 98-M-0094 |
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | May 2003 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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