Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102102
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2005-01-20
Brief Title:
Role of Substance P in Post-Traumatic Stress Disorder
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
PET Evaluation of NK1 Receptor Using 18FSPA-RQ in Post-Traumatic Stress Disorder
Status:
COMPLETED
Status Verified Date:
2006-01
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 examine the role of substance P a chemical messenger in the brain in post-traumatic stress disorder PTSD a chronic anxiety disorder PTSD can develop after exposure to a terrifying event or ordeal such as a violent personal assault natural or human-caused disaster accident or military combat Substance P is a peptide that may be important in the response to certain psychiatric and neurological diseases and conditions including anxiety
Healthy normal volunteers and people with PTSD who are between 18 and 65 years of age may be eligible for this study Candidates are screened with a physical examination blood and urine tests pregnancy test for women who can become pregnant and a neuropsychological evaluation
Participants undergo positron emission tomography PET and magnetic resonance imaging MRI scanning An optional lumbar puncture spinal tap is also requested
PET Scanning
PET uses small amounts of a radioactive chemical called a tracer that labels active areas of the brain The tracer used in this study is 18FSPA-RQ For the procedure the subject lies still on the scanner bed A special mask is fitted to the head to help keep the subjects head still during the scan so the images will be clear A 20-minute transmission scan is done before the radioactive tracer is injected to provide measures of the brain that will help in the precise calculation of information from subsequent scans After the tracer is injected through a needle in the arm pictures are taken continuously for about 2 hours Then 20- to 40-minute images are taken every hour until about 5 hours after the injection
MRI Scanning
An MRI scan is scheduled at some time within 1 year of the PET scan MRI uses a magnetic field and radio waves to obtain images of body tissues and organs The subject lies still on a table inside the tunnel-like MRI scanner Earplugs are worn to muffle loud noises that occur during the scanning The maximum duration of the scan is 60 minutes
Lumbar Puncture
Lumbar puncture is used to examine the cerebrospinal fluid CSF that surrounds both the brain and the spinal cord For this procedure a local anesthetic is given to numb the skin in the lower back area A small needle is then inserted into the space between the bones in the lower back where the CSF circulates below the spinal cord A small amount of fluid is collected through the needle
Blood Draw
A blood sample is collected to generate cell lines that can be used to extract DNA genetic material for gene studies and that can be frozen for future use
Healthy normal volunteers and people with PTSD who are between 18 and 65 years of age may be eligible for this study Candidates are screened with a physical examination blood and urine tests pregnancy test for women who can become pregnant and a neuropsychological evaluation
Participants undergo positron emission tomography PET and magnetic resonance imaging MRI scanning An optional lumbar puncture spinal tap is also requested
PET Scanning
PET uses small amounts of a radioactive chemical called a tracer that labels active areas of the brain The tracer used in this study is 18FSPA-RQ For the procedure the subject lies still on the scanner bed A special mask is fitted to the head to help keep the subjects head still during the scan so the images will be clear A 20-minute transmission scan is done before the radioactive tracer is injected to provide measures of the brain that will help in the precise calculation of information from subsequent scans After the tracer is injected through a needle in the arm pictures are taken continuously for about 2 hours Then 20- to 40-minute images are taken every hour until about 5 hours after the injection
MRI Scanning
An MRI scan is scheduled at some time within 1 year of the PET scan MRI uses a magnetic field and radio waves to obtain images of body tissues and organs The subject lies still on a table inside the tunnel-like MRI scanner Earplugs are worn to muffle loud noises that occur during the scanning The maximum duration of the scan is 60 minutes
Lumbar Puncture
Lumbar puncture is used to examine the cerebrospinal fluid CSF that surrounds both the brain and the spinal cord For this procedure a local anesthetic is given to numb the skin in the lower back area A small needle is then inserted into the space between the bones in the lower back where the CSF circulates below the spinal cord A small amount of fluid is collected through the needle
Blood Draw
A blood sample is collected to generate cell lines that can be used to extract DNA genetic material for gene studies and that can be frozen for future use
Detailed Description:
Posttraumatic stress disorder PTSD is a chronic debilitating disorder that places a significant burden on individuals and society Abnormalities in the serotonergic and noradrenergic systems and dysregulation of the hypothalamic-pituitary adrenal HPA axis have been proposed as neurobiological mechanisms in the development of the disorder however the exact underpinnings of the neurobiology of the disorder must be elucidated
Distribution of substance P SP and its receptor neurokinin 1 NK1 receptor includes regions implicated in the pathophysiology of PTSD namely the amygdala hippocampus hypothalamus and locus ceruleus There is a considerable spatial and therefore functional overlap between the SP-NK1 receptor system and other neurotransmitter eg norepinephrine serotonin pathways with well established roles in anxiety Preclinical studies indicate that stress regulates levels of SP in several brain regions In addition in several animal models NK1 receptor antagonists demonstrate anxiolytic-like property These anxiolytic-like effects seem to involve different mechanisms than those of currently available anxiolytics
In this protocol we will use a PET ligand that acts as an NK1 receptor antagonist 18FSPA-RQ 18F-labeled Substance P Antagonist Receptor Quantifier Using this tracer we will look for regional differences in NK1 receptor binding in 20 patients with PTSD and 20 healthy controls The goal of the present study is to demonstrate the involvement of SP in PTSD and thereby further our understanding of its role in the psychopathology of this illness
Distribution of substance P SP and its receptor neurokinin 1 NK1 receptor includes regions implicated in the pathophysiology of PTSD namely the amygdala hippocampus hypothalamus and locus ceruleus There is a considerable spatial and therefore functional overlap between the SP-NK1 receptor system and other neurotransmitter eg norepinephrine serotonin pathways with well established roles in anxiety Preclinical studies indicate that stress regulates levels of SP in several brain regions In addition in several animal models NK1 receptor antagonists demonstrate anxiolytic-like property These anxiolytic-like effects seem to involve different mechanisms than those of currently available anxiolytics
In this protocol we will use a PET ligand that acts as an NK1 receptor antagonist 18FSPA-RQ 18F-labeled Substance P Antagonist Receptor Quantifier Using this tracer we will look for regional differences in NK1 receptor binding in 20 patients with PTSD and 20 healthy controls The goal of the present study is to demonstrate the involvement of SP in PTSD and thereby further our understanding of its role in the psychopathology of this illness
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 |
|---|---|---|---|
| 05-M-0080 | None | None | None |