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I-123 Brain Studies of Serotonin Metabolism in Psychiatric Patients and Normal Volunteers
This study has been completed.
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001771
  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.


Condition
Healthy
Mental Disorder
Obsessive Compulsive Disorder
Schizophrenia
Tourette Syndrome

Genetics Home Reference related topics: familial encephalopathy with neuroserpin inclusion bodies familial paroxysmal nonkinesigenic dyskinesia Tourette syndrome
MedlinePlus related topics: Child Mental Health Mental Health Obsessive-Compulsive Disorder Schizophrenia Tourette Syndrome
Drug Information available for: Dopamine Dopamine hydrochloride Serotonin
U.S. FDA Resources
Study Type: Observational
Official Title: I-123 Beta-CIT SPECT Studies of Dopamine and Serotonin Transporters in Neuropsychiatric Patients and Normal Volunteers

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 112
Study Start Date: May 1998
Estimated Study Completion Date: May 2003
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001771

Locations
United States, Maryland
National Institute of Mental Health (NIMH)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
Study ID Numbers: 980094, 98-M-0094
Study First Received: November 3, 1999
Last Updated: March 3, 2008
ClinicalTrials.gov Identifier: NCT00001771  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Receptors
Re-Uptake
Neurotransmitters
Neuroimaging
Drug Abuse
Serotonin
Brain Scan
Tourette's Syndrome
Obsessive Compulsive Disorder
Schizophrenia
Normal Volunteer

Study placed in the following topic categories:
Ganglion Cysts
Basal Ganglia Diseases
Central Nervous System Diseases
Tourette Syndrome
Healthy
Tic Disorders
Neurodegenerative Diseases
Brain Diseases
Serotonin
Tics
Schizophrenia
Dopamine
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Anxiety Disorders
Movement Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Gilles de la Tourette's syndrome
Psychotic Disorders
Obsessive-Compulsive Disorder
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Agents
Serotonin Agents
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Syndrome
Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009