Back to resultsI-123 Brain Studies of Serotonin Metabolism in Psychiatric Patients and Normal Volunteers
Primary Purpose
Healthy, Mental Disorder, Obsessive Compulsive Disorder
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Healthy focused on measuring Receptors, Re-Uptake, Neurotransmitters, Neuroimaging, Drug Abuse, Serotonin, Brain Scan, Tourette's Syndrome, Obsessive Compulsive Disorder, Schizophrenia, Normal Volunteer
Eligibility 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.
Sites / Locations
- National Institute of Mental Health (NIMH)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001771
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00001771
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
Study Type
Observational
2. Study Status
Record Verification Date
May 2003
Overall Recruitment Status
Completed
Study Start Date
May 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Mental Disorder, Obsessive Compulsive Disorder, Schizophrenia, Tourette Syndrome
Keywords
Receptors, Re-Uptake, Neurotransmitters, Neuroimaging, Drug Abuse, Serotonin, Brain Scan, Tourette's Syndrome, Obsessive Compulsive Disorder, Schizophrenia, Normal Volunteer
7. Study Design
Enrollment
112 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
National Institute of Mental Health (NIMH)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
6640008
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.
Results Reference
background
PubMed Identifier
2760605
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. doi: 10.1007/BF01248935.
Results Reference
background
PubMed Identifier
8265656
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. doi: 10.1073/pnas.90.24.11965.
Results Reference
background
Learn more about this trial
I-123 Brain Studies of Serotonin Metabolism in Psychiatric Patients and Normal Volunteers
We'll reach out to this number within 24 hrs