Post-Traumatic Stress Disorder Clinical Trial
Official title:
PET Evaluation of NK1 Receptor Using [18F]SPA-RQ in Post-Traumatic Stress Disorder
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 [18F]SPA-RQ. For the procedure, the subject
lies still on the scanner bed. A special mask is fitted to the head to help keep the
subject's 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.
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 (e.g., 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,
[18F]SPA-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.
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