Post-Traumatic Stress DisorderNCT00102102
Role of Substance P in Post-Traumatic Stress Disorder
An observational study of Post-Traumatic Stress Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- [18F]SPA-RQ
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jan 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- PTSD Samples:
- Twenty subjects (age 18-65) with current PTSD, as defined by DSM-IV criteria, of any ethnicity without other significant medical conditions will be selected.
- Healthy Control Samples:
- Twenty healthy subjects (age 18-65) without a known personal or family history of psychiatric disorders in first-degree relatives will be selected.
- A control subject will be matched to each subject with PTSD for age, gender, and handedness, respectively.
- They must not be actively using illicit drugs or engaged in heavy consumption of alcohol, had no metallic implants that are ferromagnetic, and competent to sign consent forms to participate in the study.
Who cannot join
- Patients must not have taken antidepressant or other medications likely to alter SP-NK1 receptor system. Effective medications will not be discontinued for the purpose of this study.
- Subjects will be excluded if they have:
- DSM-IV Axis I diagnostic criteria other than PTSD and Major depression (All controls must not meet any of the Axis I diagnoses);
- DSM-IV criteria for psychoactive substance abuse/dependence within six months;
- take psychotropic medication in last 3 weeks (8 weeks for fluoxetine);
- abnormal MRI other than minor atrophy;
Show all 16Show fewer
- abnormal laboratory test, including HIV test;
- are currently pregnant or breast feeding (as documented by pregnancy testing at screening or at days of the scanning);
- prior participation in other research protocols within the past year such that a radiation exposure together with the present study would exceed the annual limits (A total effective dose 5.0 rem in a year and a 5 rad per year to the lens of the eyes, gonads and blood-forming organs; and 15 rad annually for all other organs);
- are unable to lay on one's back for PET/MRI scans (PET and MRI scans take approximately 5 and 1 hour, respectively);
- any condition that increases risk for MRI (e.g., pacemaker, metallic foreign body in the eye, etc.);
- individuals who recently donated blood;
- serious suicidal ideation or behavior;
- Xylocaine allergy;
- positive HIV test.
- For healthy subjects, exclusion criteria b) through m) are same to those for PTSD subjects. As for item a), subjects will be excluded if they meet any current DSM-IV Axis I diagnostic criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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 (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.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- [18F]SPA-RQ
- Keywords
- Substance P, Neurokinin, Tachykinin, Anxiety, Neuroreceptor Imaging, Post-Traumatic Stress Disorder, PTSD, Healthy Volunteer, HV
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]SPA-RQDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2005 (estimated)
- Study startJan 2005
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102102
- Sponsor's protocol ID
- 050080
- Other IDs
- 05-M-0080
- Status last verified
- Jan 2006
- First submitted
- 20 Jan 2005
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Breslau N, Kessler RC, Chilcoat HD, Schultz LR, Davis GC, Andreski P. Trauma and posttraumatic stress disorder in the community: the 1996 Detroit Area Survey of Trauma. Arch Gen Psychiatry. 1998 Jul;55(7):626-32. doi: 10.1001/archpsyc.55.7.626.
PubMed 9672053Davidson JR, Hughes D, Blazer DG, George LK. Post-traumatic stress disorder in the community: an epidemiological study. Psychol Med. 1991 Aug;21(3):713-21. doi: 10.1017/s0033291700022352.
PubMed 1946860Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB. Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry. 1995 Dec;52(12):1048-60. doi: 10.1001/archpsyc.1995.03950240066012.
PubMed 7492257
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Evaluation of NK1 Receptor Using [18F]SPA-RQ in Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00102102
- Acronym / sponsor ID
- 050080
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Substance P, Neurokinin, Tachykinin, Anxiety, Neuroreceptor Imaging, Post-Traumatic Stress Disorder, PTSD, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Jan 2005
- Study completion
- Jan 2006
- First posted
- 21 Jan 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Twenty subjects (age 18-65) with current PTSD, as defined by DSM-IV criteria, of any ethnicity without other significant medical conditions will be selected.
- Twenty healthy subjects (age 18-65) without a known personal or family history of psychiatric disorders in first-degree relatives will be selected.
- A control subject will be matched to each subject with PTSD for age, gender, and handedness, respectively.
- They must not be actively using illicit drugs or engaged in heavy consumption of alcohol, had no metallic implants that are ferromagnetic, and competent to sign consent forms to participate in the study.
Key exclusion criteria (16 listed)
- Patients must not have taken antidepressant or other medications likely to alter SP-NK1 receptor system. Effective medications will not be discontinued for the purpose of this study.
- DSM-IV Axis I diagnostic criteria other than PTSD and Major depression (All controls must not meet any of the Axis I diagnoses);
- DSM-IV criteria for psychoactive substance abuse/dependence within six months;
- take psychotropic medication in last 3 weeks (8 weeks for fluoxetine);
- abnormal MRI other than minor atrophy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]SPA-RQ | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 9672053Breslau N, Kessler RC, Chilcoat HD, Schultz LR, Davis GC, Andreski P. Trauma and posttraumatic stress disorder in the community: the 1996 Detroit Area Survey of Trauma. Arch Gen Psychiatry. 1998 Jul;55(7):626-32. doi: 10.1001/archpsyc.55.7.626.
- Background: PubMed 1946860Davidson JR, Hughes D, Blazer DG, George LK. Post-traumatic stress disorder in the community: an epidemiological study. Psychol Med. 1991 Aug;21(3):713-21. doi: 10.1017/s0033291700022352.
- Background: PubMed 7492257Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB. Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry. 1995 Dec;52(12):1048-60. doi: 10.1001/archpsyc.1995.03950240066012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Traumatic Stress Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00102102, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.