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Post-traumatic Stress Disorder (PTSD)NCT02053532

Functional Brain Imaging in PTSD

An observational study of Post-traumatic Stress Disorder (PTSD) and Trauma, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients with post-traumatic stress disorder (PTSD) have abnormalities in the function of the amygdala and medial prefrontal cortex (particularly anterior cingulate), in addition to abnormalities of hippocampal volume. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Post-traumatic Stress Disorder (PTSD), Trauma
What is being tested?
Positron emission tomography/magnetic resonance imaging
Type of treatment
Surgery or procedure
How many people
50 participants
Where
1 siteUnited States
Study dates
May 2013to Feb 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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Subjects are between the age range of 18 to 65, are medically healthy and currently not taking any medications to treat any medical illness, and either have no history of post-traumatic stress disorder (PTSD) or have been diagnosed with PTSD.

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
  • . Age 18-55 years old;
  • . No personal or first-degree family history of any Axis I diagnosis;
  • . Has a lifetime history of trauma.

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 (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
  • nicotine dependence
Show all 54Show fewer
  • suicidal ideation or behavior
  • general magnetic resonance imaging (MRI) exclusion criteria, i.e. pacemakers, metals in the body;
  • Human immunodeficiency virus (HIV) (due to possible neuropsychiatric effects)
  • Hepatitis B or C (due to possible neuropsychiatric effects)
  • use of opioid medications within 2 weeks of the positron emission tomography (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
  • positive alcohol breathalyzer test
  • Abnormal thyroid test indicated by thyroid stimulating hormone (TSH) < .15 mlU/L and/or thyroxine (T4) > 18 mcg/dL
  • Glucose > 200 mg/dL on two separate days
  • For Healthy Subjects
  • . 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;
  • . nicotine dependence;
  • . suicidal ideation or behavior;
  • . general MRI exclusion criteria, i.e. pacemakers, metals in the body;
  • . HIV (due to possible neuropsychiatric effects);
  • . Hepatitis B or C (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;
  • . positive alcohol breathalyzer test;
  • . Abnormal thyroid test indicated by TSH < .15 mlU/L and/or T4 > 18 mcg/dL;
  • . Glucose > 200 mg/dL on two separate days;
  • . Does not have a lifetime history of trauma.
  • For Healthy Subjects with Trauma ("Trauma Controls")
  • . 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;
  • . nicotine dependence;
  • . suicidal ideation or behavior;
  • . general MRI exclusion criteria, i.e. pacemakers, metals in the body;
  • . HIV (due to possible neuropsychiatric effects);
  • . Hepatitis B or C (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;
  • . positive alcohol breathalyzer test;
  • . Abnormal thyroid test indicated by TSH < .15 mlU/L and/or T4 > 18 mcg/dL;
  • . Glucose > 200 mg/dL on two separate days.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • NYU School of Medicine

    New York, New York, 10016

Other trials in United States

About this study

Patients with post-traumatic stress disorder (PTSD) have abnormalities in the function of the amygdala and medial prefrontal cortex (particularly anterior cingulate), in addition to abnormalities of hippocampal volume. In this pilot study we propose to use the combined positron emission tomography/magnetic resonance (PET/MR) scanner and F-18-fluorodeoxyglucose (FDG, an analog of glucose, the most commonly used PET ligand) to examine brain function and directly correlate the data with the intrinsic functional connectivity of brain circuits that are responsible for social, emotional and cognitive processing in both individuals with PTSD and group-matched trauma controls (TC) and healthy controls (HC). Once the machine is validated, we will then use a more specific biomarker to better understand the neurochemical factors that contribute to individual differences in PTSD. Thus, the data obtained from this pilot study will guide our future molecular imaging studies. The link between general brain function, specific molecular target and the intrinsic functional connectivity of brain circuits that are responsible for social, emotional and cognitive processing in PTSD, TC and HC will be explored.

Being tested
Positron emission tomography/magnetic resonance imaging
Keywords
Trauma, Post-traumatic stress disorder (PTSD), Imaging, Neuroimaging, F-18-fluorodeoxyglucose (FDG)
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/magnetic resonance imagingProcedure or surgery

    Also called PET Imaging

    Positron emission tomography/magnetic resonance (PET/MR) imaging using 18-F-fluorodeoxyglucose (FDG) as radio tracer

Study groups in NCT02053532
Study groupRoleWhat they receive
Positron emission tomography/magnetic resonance imagingNot described
Receives: Procedure: Positron emission tomography/magnetic resonance imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. F-18- fluorodeoxyglucose (FDG) metabolism in the brain of healthy controls (HC) vs trauma controls (TC) vs individuals with post-traumatic stress disorder (PTSD)

    In this pilot study we propose to use the combined positron emission tomography/magnetic resonance (PET/MR) scanner and F-18-fluorodeoxyglucose (FDG, an analog of glucose, the most commonly used PET ligand) to examine brain function and directly correlate the data with the intrinsic functional connectivity of brain circuits that are responsible for social, emotional and cognitive processing in both individuals with post-traumatic stress disorder (PTSD) and group-matched trauma controls (TC) and healthy controls (HC). These groups are matched based on gender, age and ethnicity. Once the machine is validated, we will then use a more specific biomarker to better understand the neurochemical factors that contribute to individual differences in PTSD. The link between general brain function, specific molecular target and the intrinsic functional connectivity of brain circuits that are responsible for social, emotional and cognitive processing in PTSD, TC and HC will be explored.

    Measured: Two months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2014 (estimated)
  2. Study startMay 2013
  3. Primary completionMar 2015
  4. Study completionFeb 2016

Resources

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02053532
Sponsor's protocol ID
S13-00313
Status last verified
Mar 2016
First submitted
22 Jan 2014
Last updated
3 Mar 2016
Results posted
No
Data monitoring committee
Yes

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 7 inclusion and 54 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 3 Mar 2016. 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.

What does the primary outcome measure?

F-18- fluorodeoxyglucose (FDG) metabolism in the brain of healthy controls (HC) vs trauma controls (TC) vs individuals with post-traumatic stress disorder (PTSD) (time frame: Two months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02053532.

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 3 Mar 2016.

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