Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001320
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Neuroimaging of Dopamine Metabolism in Normal and Psychiatric Patients
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
I-123 Iodobenzamide IBZM SPECT Studies of D2 Receptor Distribution and Function in Patients With Schizophrenia and Normal Volunteers
Status:
COMPLETED
Status Verified Date:
2003-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Brain cells communicate with each other by releasing chemicals called neurotransmitters In order for brain cells to transfer information one cell will release a neurotransmitter that will be recognized by a receptor located on surface of another cell One such neurotransmitter is dopamine
Abnormal dopamine transmission has been seen in patients with substance abuse and different neuropsychiatric disorders including schizophrenia
A radioactive drug called IZBM I-123 iodobenzamide can also bind to certain dopamine receptors IZBM can be seen by Single Photon Emission Tomography SPECT Therefore by using IZBM and SPECT scans researchers can find and map the location of dopamine receptors in the brain
Patients participating in this study must also have been selected for other genetic studies being conducted at the NIMH Patients with schizophrenia will be selected from a NIMH research study titled Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings 95-M-0150 Normal patient volunteers will be selected from another NIMH study titled Inpatient Evaluation of Neuropsychiatric Patients 89-M-0160 All aspects of clinical care and genetic analysis of these patients will be covered in these studies while information pertaining to IBZM SPECT scans will be covered in this study
This study will not directly benefit patients participating in it However information gathered may contribute to faster and more accurate diagnosis of schizophrenia and eventually better treatment for the disorder
Abnormal dopamine transmission has been seen in patients with substance abuse and different neuropsychiatric disorders including schizophrenia
A radioactive drug called IZBM I-123 iodobenzamide can also bind to certain dopamine receptors IZBM can be seen by Single Photon Emission Tomography SPECT Therefore by using IZBM and SPECT scans researchers can find and map the location of dopamine receptors in the brain
Patients participating in this study must also have been selected for other genetic studies being conducted at the NIMH Patients with schizophrenia will be selected from a NIMH research study titled Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings 95-M-0150 Normal patient volunteers will be selected from another NIMH study titled Inpatient Evaluation of Neuropsychiatric Patients 89-M-0160 All aspects of clinical care and genetic analysis of these patients will be covered in these studies while information pertaining to IBZM SPECT scans will be covered in this study
This study will not directly benefit patients participating in it However information gathered may contribute to faster and more accurate diagnosis of schizophrenia and eventually better treatment for the disorder
Detailed Description:
Abnormalities in dopaminergic neurotransmission have been described in substance abuse and different neuropsychiatric disorders including schizophrenia I-123 IBZM is a radioligand that has been widely employed for SPECT imaging of dopamine type 2 and type 3 receptors D2 and D3 respectively and fluctuations in levels of endogenous dopamine I-123 IBZM SPECT has been used in the SPECT Lab of the Clinical Brain Disorders Branch for several years without adverse effects Pharmacological effects of IBZM are unlikely due to the minimal amounts used and have not been observed We propose to use I-123 IBZM SPECT to explore following questions 1 Can a previously found relationship between N-acetylaspartate NAA measures in the dorsolateral prefrontal cortex and striatal dopamine activity in patients with schizophrenia be replicated and is it also found in normal subjects 2 Do allelic variants of genes for the dopamine type 2 DRD2 and type 3 DRD3 receptors the dopamine transporter SLC6A3 or enzymes involved in dopamine biosynthesis TH and metabolism COMT MAOA affect D2 receptor availability in vivo
This technical protocol describes the procedural aspects of I-123IBZM SPECT It is not intended to be sufficient on its own for a clinical study All subjects volunteering for this study will be recruited from among individuals who have previously consented to participate in clinical studies under one of two NIH protocols that include genetic testing Schizophrenia patients will be recruited from among NIMH inpatients participating under NIH protocol 89-M-0160 Inpatient Evaluation of Neuropsychiatric Patients Egan 1999a Normal volunteers will be recruited from among those participating under NIH protocol 95-M-0150 A Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings Egan 1999b which includes recruitment of a normal control group whose first degree relatives are free of mental illness All details related to clinical care and genetic analysis are contained in those two protocols and their associated consent forms all details related to I-123IBZM SPECT studies per se are discussed in this protocol which requires a separate informed consent from each volunteer
This technical protocol describes the procedural aspects of I-123IBZM SPECT It is not intended to be sufficient on its own for a clinical study All subjects volunteering for this study will be recruited from among individuals who have previously consented to participate in clinical studies under one of two NIH protocols that include genetic testing Schizophrenia patients will be recruited from among NIMH inpatients participating under NIH protocol 89-M-0160 Inpatient Evaluation of Neuropsychiatric Patients Egan 1999a Normal volunteers will be recruited from among those participating under NIH protocol 95-M-0150 A Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings Egan 1999b which includes recruitment of a normal control group whose first degree relatives are free of mental illness All details related to clinical care and genetic analysis are contained in those two protocols and their associated consent forms all details related to I-123IBZM SPECT studies per se are discussed in this protocol which requires a separate informed consent from each volunteer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 92-M-0024 | None | None | None |