Posttraumatic Stress DisorderPhase 1NCT01799837
Norepinephrine Transporter Availability in PTSD
A Phase 1 study testing [C-11]MENET in people with Posttraumatic Stress Disorder, run by Emory University at 1 site in United States.
Trial summary
The objective of this proposal is to collect pilot data to characterize the binding of [11C]MENET in combat-exposed war veterans with posttraumatic stress disorder (PTSD). Approximately two hundred thousand veterans will be returning stateside upon the end of combat operations in Iraq, and 13% of returning veterans… Read more about this study
- Who is it for?
- Ages 30 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- [C-11]MENET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jul 2013
- Phase
- Phase 1
- 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 30 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PTSD as determined by the Structural Clinical Interview for DSMIV (SCID) interview of PTSD and the Clinical Administered PTSD Scale (CAPS).
- Veteran with history of active duty service and currently discharged from active duty service
- Free of psychotropic medication for four weeks before the study
Who cannot join
- History of shrapnel or other foreign bodies which would preclude MRI scanning
- Meningitis
- Traumatic brain injury
- Neurological disorder or organic mental disorder
- History of loss of consciousness
- Current or lifetime history of alcohol abuse or substance abuse or dependence base on the SCID
Show all 11Show fewer
- Current or lifetime history of schizophrenia, schizoaffective disorder, or bulimia based on the SCID
- History of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness
- Evidence of a major or neurological illness on physical examination or as a result of laboratory studies
- positive urine toxicology screen
- Current steroid use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kinetic Modeling of Norepinephrine Transporter Availability in PTSD
The objective of this proposal is to collect pilot data to characterize the binding of [11C]MENET in combat-exposed war veterans with posttraumatic stress disorder (PTSD). Approximately two hundred thousand veterans will be returning stateside upon the end of combat operations in Iraq, and 13% of returning veterans will have PTSD. 15% of all war veterans will develop chronic PTSD symptoms requiring a lifetime of mental health care. Little is known about the dysregulation of PTSD veteran's neurochemical state including the noradrenergic system which plays a primary role in memory and stress response. This includes heightened anxiety, fear and hyperarousal symptoms characteristic of PTSD. The noradrenergic system is a concentration of neurons in the brainstem nucleus, locus coerulues, that have projections to the amygdale and prefrontal cortex. The norepinephrine transporter (NET) is responsible for regulating and terminating noradrenergic transmission, and is a specific marker for neuronal integrity. Hyperactivity of the noradrenergic system up-regulates NET protein. An unresolved problem in studying the noradrenergic system is identification of suitable radiopharmaceutical to non-invasively measure alterations in the density of NET. The investigators propose to address this challenge by using positron emission tomography (PET) to measure stress-induced changes in NET expression in combat-exposed war veterans with PTSD. The central hypothesis of this proposal is that war veterans with PTSD have an up-regulation of NET in the locus coerulues resulting from hyperactivity of the noradrenergic system compared to healthy controls. Through a series of experiments, the investigators will determine the in vivo binding characteristics of [11C]MENET. The investigators will use this information to optimally design an experimental protocol to measure the availability of NET in a pilot group of combat-exposed war veterans with PTSD. The aims of this proposal are: 1) Measure the uptake kinetics and whole brain distribution of [11C]MENET in combat-exposed veterans with PTSD and healthy controls, 2) Develop a quantitative kinetic model of [11C]MENET uptake to calculate the NET availability in brain. The subjects undergoing imaging in this work will be recruited by Dr. J. Douglas Bremner (Co-Investigator) at Emory University and Atlanta Veteran Affairs Hospital. Our long-term goal is to develop a longitudinal study framework to assess the NETs dysregulation during onset of PTSD as well as its transition to chronic lifetime PTSD.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- [C-11]MENET
- Keywords
- PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[C-11]MENETDrug
Also called (2S,3S)-2-[alpha-(2-[11C]- methylphenoxy)phenylmethyl]morpholine([11C]MENET)
PET imaging involves injecting small amounts of a radioactive material into the blood stream. The radioactive material is attached to a drug called MENET that will give information about how the brain interacts with a protein called norepinephrine (NE).
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Other | Posttraumatic stress disorder (PTSD) is a potentially debilitating anxiety disorder triggered when a person is exposed to a traumatic event that is beyond what is experienced in everyday life. A traumatic event may include an interpersonal event like physical or sexual assault, exposure to a disaster or accidents, combat or witnessing a traumatic event. Some symptoms of PTSD include not being able to sleep, nightmares, flashbacks of the event and having problems with memory or not being able to focus. You are being asked to volunteer because you are either 1) a normal healthy volunteer or 2) a deployed veteran or non-deployed veteran who is diagnosed with PTSD. We anticipate enrolling 16 subjects; 8 veterans with PTSD and 8 healthy volunteers without PTSD. Receives: Drug: [C-11]MENET |
| Veterans with PTSD | Other | Posttraumatic stress disorder (PTSD) is a potentially debilitating anxiety disorder triggered when a person is exposed to a traumatic event that is beyond what is experienced in everyday life. A traumatic event may include an interpersonal event like physical or sexual assault, exposure to a disaster or accidents, combat or witnessing a traumatic event. Some symptoms of PTSD include not being able to sleep, nightmares, flashbacks of the event and having problems with memory or not being able to focus. You are being asked to volunteer because you are either 1) a normal healthy volunteer or 2) a deployed veteran or non-deployed veteran who is diagnosed with PTSD. We anticipate enrolling 16 subjects; 8 veterans with PTSD and 8 healthy volunteers without PTSD. Receives: Drug: [C-11]MENET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of norepinephrine availability
Information to be obtained are [11C]MENET PET scans including arterial blood sampling to measure blood metabolites.[11C]MENET PET images will be analyze with a full compartmental kinetic analysis. Arterial blood and reference tissue input functions will be used to calculate the distribution volume ratio and binding potential of NET availability in each group
Measured: Participants will be followed for the duration of the hospital stay, an expected average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startJun 2012
- Primary completionApr 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathon Nye, Emory University
- Investigators
- Jonathon A Nye, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799837
- Sponsor's protocol ID
- IRB00057641
- Other IDs
- URC-00025435
- Status last verified
- Sep 2013
- First submitted
- 13 Dec 2012
- Last updated
- 11 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetic Modeling of Norepinephrine Transporter Availability in PTSD
- ClinicalTrials.gov ID
- NCT01799837
- Acronym / sponsor ID
- IRB00057641
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 27 Feb 2013 (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.
The objective of this proposal is to collect pilot data to characterize the binding of [11C]MENET in combat-exposed war veterans with posttraumatic stress disorder (PTSD). Approximately two hundred thousand veterans will be returning stateside upon the end of combat operations in Iraq, and 13% of returning veterans will have PTSD. 15% of all war veterans will develop chronic PTSD symptoms requiring a lifetime of mental health care. Little is known about the dysregulation of PTSD veteran's neurochemical state including the noradrenergic system which plays a primary role in memory and stress response. This includes heightened anxiety, fear and hyperarousal symptoms characteristic of PTSD. The noradrenergic system is a concentration of neurons in the brainstem nucleus, locus coerulues, that have projections to the amygdale and prefrontal cortex. The norepinephrine transporter (NET) is responsible for regulating and terminating noradrenergic transmission, and is a specific marker for neuronal integrity. Hyperactivity of the noradrenergic system up-regulates NET protein. An unresolved problem in studying the noradrenergic system is identification of suitable radiopharmaceutical to non-invasively measure alterations in the density of NET. The investigators propose to address this challenge by using positron emission tomography (PET) to measure stress-induced changes in NET expression in combat-exposed war veterans with PTSD. The central hypothesis of this proposal is that war veterans with PTSD have an up-regulation of NET in the locus coerulues resulting from hyperactivity of the noradrenergic system compared to healthy controls. Through a series of experiments, the investigators will determine the in vivo binding characteristics of [11C]MENET. The investigators will use this information to optimally design an experimental protocol to measure the availability of NET in a pilot group of combat-exposed war veterans with PTSD. The aims of this proposal are: 1) Measure the uptake kinetics and whole brain distribution of [11C]MENET in combat-exposed veterans with PTSD and healthy controls, 2) Develop a quantitative kinetic model of [11C]MENET uptake to calculate the NET availability in brain. The subjects undergoing imaging in this work will be recruited by Dr. J. Douglas Bremner (Co-Investigator) at Emory University and Atlanta Veteran Affairs Hospital. Our long-term goal is to develop a longitudinal study framework to assess the NETs dysregulation during onset of PTSD as well as its transition to chronic lifetime PTSD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Other | Drug: [C-11]MENETPosttraumatic stress disorder (PTSD) is a potentially debilitating anxiety disorder triggered when a person is exposed to a traumatic event that is beyond what is experienced in everyday life. A traumatic event may include an interpersonal event like physical or sexual assault, exposure to a disaster or accidents, combat or witnessing a traumatic event. Some symptoms of PTSD include not being able to sleep, nightmares, flashbacks of the event and having problems with memory or not being able to focus. You are being asked to volunteer because you are either 1) a normal healthy volunteer or 2) a deployed veteran or non-deployed veteran who is diagnosed with PTSD. We anticipate enrolling 16 subjects; 8 veterans with PTSD and 8 healthy volunteers without PTSD. |
| Veterans with PTSD | Other | Drug: [C-11]MENETPosttraumatic stress disorder (PTSD) is a potentially debilitating anxiety disorder triggered when a person is exposed to a traumatic event that is beyond what is experienced in everyday life. A traumatic event may include an interpersonal event like physical or sexual assault, exposure to a disaster or accidents, combat or witnessing a traumatic event. Some symptoms of PTSD include not being able to sleep, nightmares, flashbacks of the event and having problems with memory or not being able to focus. You are being asked to volunteer because you are either 1) a normal healthy volunteer or 2) a deployed veteran or non-deployed veteran who is diagnosed with PTSD. We anticipate enrolling 16 subjects; 8 veterans with PTSD and 8 healthy volunteers without PTSD. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- PTSD as determined by the Structural Clinical Interview for DSMIV (SCID) interview of PTSD and the Clinical Administered PTSD Scale (CAPS).
- Veteran with history of active duty service and currently discharged from active duty service
- Free of psychotropic medication for four weeks before the study
Key exclusion criteria (11 listed)
- History of shrapnel or other foreign bodies which would preclude MRI scanning
- Meningitis
- Traumatic brain injury
- Neurological disorder or organic mental disorder
- History of loss of consciousness
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 |
|---|---|---|
| [C-11]MENETAlso: (2S,3S)-2-[alpha-(2-[11C]- methylphenoxy)phenylmethyl]morpholine([11C]MENET)PET imaging involves injecting small amounts of a radioactive material into the blood stream. The radioactive material is attached to a drug called MENET that will give information about how the brain interacts with a protein called norepinephrine (NE). | Drug | Healthy Controls, Veterans with PTSD |
Primary outcome
Measurement of norepinephrine availability
Time frame: Participants will be followed for the duration of the hospital stay, an expected average of 1 day
Information to be obtained are [11C]MENET PET scans including arterial blood sampling to measure blood metabolites.[11C]MENET PET images will be analyze with a full compartmental kinetic analysis. Arterial blood and reference tissue input functions will be used to calculate the distribution volume ratio and binding potential of NET availability in each group
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 11 Sep 2013.
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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.
Jonathon A Nye, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [C-11]MENET in people with Posttraumatic Stress Disorder, run by Emory University 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 3 inclusion and 11 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 11 Sep 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Measurement of norepinephrine availability (time frame: Participants will be followed for the duration of the hospital stay, an expected average of 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2013.