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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001771
• Other study ID #: 980094
• Secondary ID: 98-M-0094
• Status: Completed
• Phase: N/A
• First received: November 3, 1999
• Last updated: March 3, 2008
• Start date: May 1998
• Est. completion date: May 2003

Study information

• Verified date: May 2003
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: May 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Compulsive Behavior
• Disease
• Healthy
• Mental Disorder
• Mental Disorders
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder
• Psychotic Disorders
• Schizophrenia
• Tourette Syndrome

Locations

Country	Name	City	State
United States	National Institute of Mental Health (NIMH)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bogerts B, Häntsch 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. — View 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. — View 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. — View Citation