Expired Study
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Bethesda, Maryland 20892


Purpose:

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 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.


Criteria:

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.


Study is Available At:


Original ID:

980094


NCT ID:

NCT00001771


Secondary ID:

98-M-0094


Study Acronym:


Brief Title:

I-123 Brain Studies of Serotonin Metabolism in Psychiatric Patients and Normal Volunteers


Official Title:

I-123 Beta-CIT SPECT Studies of Dopamine and Serotonin Transporters in Neuropsychiatric Patients and Normal Volunteers


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institutes of Health Clinical Center (CC)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Observational


Study Design:

N/A


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

112


Enrollment Type:


Study Dates

Start Date:May 1998
Completion Date:May 2003
Verification Date:May 2003
Last Changed Date:March 3, 2008
First Received Date:November 3, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Innis RB, Seibyl JP, Scanley BE, Laruelle M, Abi-Dargham A, Wallace E, Baldwin RM, Zea-Ponce Y, Zoghbi S, Wang S, et al. Single photon emission computed tomographic imaging demonstrates loss of striatal dopamine transporters in Parkinson disease. Proc Natl Acad Sci U S A. 1993 Dec 15;90(24):11965-9.
PMID:8265656
Reference Type:Reference
Citation:Czudek C, Reynolds GP. [3H] GBR 12935 binding to the dopamine uptake site in post-mortem brain tissue in schizophrenia. J Neural Transm. 1989;77(2-3):227-30.
PMID:2760605
Reference Type:Reference
Citation:Bogerts B, Hantsch J, Herzer M. A morphometric study of the dopamine-containing cell groups in the mesencephalon of normals, Parkinson patients, and schizophrenics. Biol Psychiatry. 1983 Sep;18(9):951-69.
PMID:6640008

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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