Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082550
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-05-12
Brief Title:
Serotonin Transporters in Obsessive-Compulsive-Related Disorders
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
PET Imaging of Monoamine Transporters in OCD-related Disorders
Status:
COMPLETED
Status Verified Date:
2007-04-09
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:
This study will compare serotonin transporters in patients with obsessive-compulsive disorder OCD and healthy volunteers in order to better understand the role of serotonin in OCD Serotonin is a chemical in the brain that transmits nerve impulses The serotonin transporter SERT is a protein that regulates serotonin levels in the brain
Normal healthy volunteers and patients with OCD between 18 and 50 years of age and in overall good health may be eligible for this study Candidates are screened with a medical history physical examination blood and urine tests and a psychological interview and tests related to OCD symptoms Participants undergo the following tests
Positron emission tomography PET scanning For this test subjects lie on the scanner bed wearing special masks that are fitted to their heads and attached to the beds to help keep their heads still during the procedure An 8-minute transmission scan is done to provide measures of the brain that will help calculate information obtained from subsequent scans Then a radioactive tracer is injected into a catheter plastic tube placed in the arm The scan produces images of the serotonin transporters in the brain Pictures are taken for about 2 hours while the subject lies still on the scanner bed
Magnetic resonance imaging MRI scanning An MRI scan of the brain is done within 1 year of the PET scan-that is up to 1 year before or 1 year after the PET scan MRI uses a magnetic field and radio waves to produce images of body tissues and organs For this procedure the patient lies on a table that is moved into the scanner a narrow cylinder wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process The procedure lasts about 1 hour during which the patient will be asked to lie still for up to a few minutes at a time
Genotyping Subjects provide a blood sample 4 tablespoons for DNA testing to look for genes or gene regions that may contribute to serotonin activity This may lead to a better understanding of the genetic underpinnings of the serotonin system that influence mood movement and addiction
Normal healthy volunteers and patients with OCD between 18 and 50 years of age and in overall good health may be eligible for this study Candidates are screened with a medical history physical examination blood and urine tests and a psychological interview and tests related to OCD symptoms Participants undergo the following tests
Positron emission tomography PET scanning For this test subjects lie on the scanner bed wearing special masks that are fitted to their heads and attached to the beds to help keep their heads still during the procedure An 8-minute transmission scan is done to provide measures of the brain that will help calculate information obtained from subsequent scans Then a radioactive tracer is injected into a catheter plastic tube placed in the arm The scan produces images of the serotonin transporters in the brain Pictures are taken for about 2 hours while the subject lies still on the scanner bed
Magnetic resonance imaging MRI scanning An MRI scan of the brain is done within 1 year of the PET scan-that is up to 1 year before or 1 year after the PET scan MRI uses a magnetic field and radio waves to produce images of body tissues and organs For this procedure the patient lies on a table that is moved into the scanner a narrow cylinder wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process The procedure lasts about 1 hour during which the patient will be asked to lie still for up to a few minutes at a time
Genotyping Subjects provide a blood sample 4 tablespoons for DNA testing to look for genes or gene regions that may contribute to serotonin activity This may lead to a better understanding of the genetic underpinnings of the serotonin system that influence mood movement and addiction
Detailed Description:
Evidence suggests that the symptoms of obsessive-compulsive disorder OCD arise from dysfunction of both the serotonergic and dopaminergic neurotransmitter systems These two neurotransmitter systems are presumed to play a key modulatory role at the limbic-motor interface of the fronto-subcortical circuitry However in vivo knowledge linking the serotonergic and dopaminergic systems to OCD and OCD-related disorders is limited In the current protocol we plan to use PET to image the serotonin transporter SERT within the new radioligand 11CDASB in order to delineate regional abnormalities in SERT binding in drug-naive or drug-free OCD patients in comparison to healthy volunteers In addition we plan to examine the relationship between the regional PET measures of SERT and clinical severity measures of OCD The goal of the present study is thus to further our understanding of the role of the serotonergic system in the pathophysiology of OCD
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 |
|---|---|---|---|
| 04-M-0180 | None | None | None |