Post-traumatic Stress Disorder (PTSD)NCT02237703
Kappa Opioid Receptor Imaging in Post-traumatic Stress Disorder (PTSD)
An observational study of Post-traumatic Stress Disorder (PTSD) and Trauma, run by NYU Langone Health at 1 site in United States.
Trial summary
This study uses positron emission tomography (PET) imaging to measure kappa opioid receptors (KOR) in the brains of individuals with and without post-traumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic Stress Disorder (PTSD), Trauma
- What is being tested?
- Positron emission tomography (PET) imaging
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Aug 2016
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects are between the age range of 18 to 55, are medically healthy and currently not taking any medications to treat any medical illness, have a history of post-traumatic stress disorder, or are a healthy control who has or has not been exposed to trauma.
Who may be able to join
- age 18-55 years old
- currently diagnosed with PTSD and symptomatic with a Clinician-Administered PTSD Scale (CAPS) score > 50.
- age 18-55 years old
- no personal or first-degree family history of any Axis I diagnosis.
Who cannot join
- any primary Axis I disorder other than PTSD (e.g. psychosis)
- medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders
- a history of drug (including benzodiazepines (BZD)) dependence (Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria) within 1 year of the study and lasting longer than 2 years, except for alcohol dependence
- current pregnancy (as documented by pregnancy testing at screening or on the day of PET imaging study)
- current breast feeding
- use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day, or cannot abstain from smoking during the prescribed tests
Show all 26Show fewer
- acute suicidal ideation or behavior, as defined by suicidal ideation and behavior during the 3-month period prior to enrollment in the study and while being enrolled in the study
- general MRI exclusion criteria, i.e. pacemakers, metals in the body
- Human immunodeficiency virus (HIV) (due to possible neuropsychiatric effects);
- use of opioid medications within 2 weeks of the PET study
- having an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participation in the study
- seriously claustrophobic
- blood donation within 8 weeks prior to the study.
- any history or current primary Axis I disorder
- medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders
- a history of drug (including benzodiazepines [BZD]) dependence (DSM IV criteria) within 1 year of the study and lasting longer than 2 years, except for alcohol dependence
- current pregnancy (as documented by pregnancy testing at screening or on the day of PET imaging study)
- current breast feeding
- use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day, or cannot abstain from smoking during the prescribed tests
- acute suicidal ideation or behavior, as defined by suicidal ideation and behavior during the 3-month period prior to enrollment in the study and while being enrolled in the study
- general MRI exclusion criteria, i.e. pacemakers, metals in the body
- HIV (due to possible neuropsychiatric effects)
- use of opioid medications within 2 weeks of the PET study
- having an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participation in the study
- seriously claustrophobic
- blood donation within 8 weeks prior to the study
Trial locations and contacts
1 site in 1 country.
About this study
This study uses positron emission tomography (PET) imaging to measure kappa opioid receptors (KOR) in the brains of individuals with and without post-traumatic stress disorder (PTSD). The investigators propose to recruit 45 drug-naïve individuals, N=15 patients with PTSD, N=15 trauma-exposed, but asymptomatic healthy control subjects (TC) and N=15 non-trauma exposed healthy control subjects (HC) to participate in one magnetic resonance imaging (MRI) and one PET study. The investigators will also carefully document trauma history, and collect behavioral and neuroendocrine measures to provide a more integrative view on the neurobiology of PTSD and its phenotype. The investigators predict PTSD will show greater carbon - 11 (11C)[11C]LY2795050 volume of distribution (VT) (i.e. KOR binding) values than control populations in an a priori defined PTSD circuit.
- Conditions
- Post-traumatic Stress Disorder (PTSD), Trauma
- Being tested
- Positron emission tomography (PET) imaging
- Keywords
- Post-traumatic Stress Disorder (PTSD), Positron emission tomography (PET), Neuroimaging, Kappa opioid receptor (KOR)
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron emission tomography (PET) imagingOther
Positron emission tomography (PET) imaging
| Study group | Role | What they receive |
|---|---|---|
| Post-traumatic stress disorder (PTSD) | Post-traumatic stress disorder (PTSD) Receives: Other: Positron emission tomography (PET) imaging | |
| Trauma Control (TC) | Trauma Control (TC) Receives: Other: Positron emission tomography (PET) imaging | |
| Healthy Control (HC) | Healthy Control (HC) Receives: Other: Positron emission tomography (PET) imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of distribution (VT) of cerebral KOR expression in PTSD and healthy control subjects with and without trauma history using the KOR radioligand [11C]LY2795050 and PET
To examine group differences in cerebral KOR expression in PTSD and healthy control subjects with and without trauma history using the KOR radioligand [11C]LY2795050 and PET.
Hypothesis: PTSD will show greater [11C]LY2795050 VT (i.e. KOR binding) values than control populations in an a priori defined PTSD circuit.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startMar 2012
- Primary completionMar 2015
- Study completionAug 2016
Why it stopped: The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Charles Marmar, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237703
- Sponsor's protocol ID
- S12-01521
- Status last verified
- Jan 2017
- First submitted
- 9 Sep 2014
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kappa Opioid Receptor Imaging in Post-traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT02237703
- Acronym / sponsor ID
- S12-01521
- Conditions
- Post-traumatic Stress Disorder (PTSD), Trauma
- Keywords
- Post-traumatic Stress Disorder (PTSD), Positron emission tomography (PET), Neuroimaging, Kappa opioid receptor (KOR)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- Mar 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 11 Sep 2014 (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 uses positron emission tomography (PET) imaging to measure kappa opioid receptors (KOR) in the brains of individuals with and without post-traumatic stress disorder (PTSD). The investigators propose to recruit 45 drug-naïve individuals, N=15 patients with PTSD, N=15 trauma-exposed, but asymptomatic healthy control subjects (TC) and N=15 non-trauma exposed healthy control subjects (HC) to participate in one magnetic resonance imaging (MRI) and one PET study. The investigators will also carefully document trauma history, and collect behavioral and neuroendocrine measures to provide a more integrative view on the neurobiology of PTSD and its phenotype. The investigators predict PTSD will show greater carbon - 11 (11C)[11C]LY2795050 volume of distribution (VT) (i.e. KOR binding) values than control populations in an a priori defined PTSD circuit.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Post-traumatic stress disorder (PTSD) | – | Other: Positron emission tomography (PET) imagingPost-traumatic stress disorder (PTSD) |
| Trauma Control (TC) | – | Other: Positron emission tomography (PET) imagingTrauma Control (TC) |
| Healthy Control (HC) | – | Other: Positron emission tomography (PET) imagingHealthy Control (HC) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects are between the age range of 18 to 55, are medically healthy and currently not taking any medications to treat any medical illness, have a history of post-traumatic stress disorder, or are a healthy control who has or has not been exposed to trauma.
Key inclusion criteria (4 listed)
- age 18-55 years old
- currently diagnosed with PTSD and symptomatic with a Clinician-Administered PTSD Scale (CAPS) score > 50.
- age 18-55 years old
- no personal or first-degree family history of any Axis I diagnosis.
Key exclusion criteria (26 listed)
- any primary Axis I disorder other than PTSD (e.g. psychosis)
- medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders
- a history of drug (including benzodiazepines (BZD)) dependence (Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria) within 1 year of the study and lasting longer than 2 years, except for alcohol dependence
- current pregnancy (as documented by pregnancy testing at screening or on the day of PET imaging study)
- current breast feeding
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 |
|---|---|---|
| Positron emission tomography (PET) imagingPositron emission tomography (PET) imaging | Other | Healthy Control (HC), Post-traumatic stress disorder (PTSD), Trauma Control (TC) |
Primary outcome
Volume of distribution (VT) of cerebral KOR expression in PTSD and healthy control subjects with and without trauma history using the KOR radioligand [11C]LY2795050 and PET
Time frame: Two months
To examine group differences in cerebral KOR expression in PTSD and healthy control subjects with and without trauma history using the KOR radioligand [11C]LY2795050 and PET. Hypothesis: PTSD will show greater [11C]LY2795050 VT (i.e. KOR binding) values than control populations in an a priori defined PTSD circuit.
Results and safety
The study was stopped early (reason given: The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
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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.
Charles Marmar, MD principal investigator
NYU School of Medicine
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 (PTSD) and Trauma, run by NYU Langone Health 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 4 inclusion and 26 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: stopped early, as of the sponsor's last update on 20 Jan 2017. 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 was stopped early (reason given: The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.). Results are not available in the source record.
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?
Volume of distribution (VT) of cerebral KOR expression in PTSD and healthy control subjects with and without trauma history using the KOR radioligand [11C]LY2795050 and PET (time frame: Two months). 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 20 Jan 2017.