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Striatal Dopamine Transporter Density in Post-Traumatic Stress Disorder (PTSD)

Primary Purpose

Post-traumatic Stress Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI using DaTscan
Sponsored by
St. Joseph's Hospital and Medical Center, Phoenix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Post-traumatic Stress Disorder focused on measuring post-traumatic stress disorder, dopamine, biomarker

Eligibility Criteria

22 Years - 39 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Males
  • Diagnosed with PTSD (n=25) or designated combat-experienced controls (n=25)

Exclusion Criteria:

  • Head trauma resulting in loss of consciousness
  • Co-morbid DSM IV Axis I psychiatric disorder
  • hyper- or hypo-thyroidism, neurological motor deficits (e.g. Parkinsonism, tremor)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    PTSD Diagnosed

    Designated Combat-Experienced Controls

    Arm Description

    Veterans exposed to combat and diagnosed with PTSD. MRI using DaTscan.

    Veterans exposed to combat, but never diagnosed with PTSD. MRI using DaTscan.

    Outcomes

    Primary Outcome Measures

    DaTscan intensity
    Visually recognizable increases in striatal DaTscan intensity in PTSD patients.
    Quantifiable differences
    Quantifiable differences in global and regional DAT density in PTSD patients and combat-experienced controls.

    Secondary Outcome Measures

    Striatal correlations
    Global and regional striatal correlations of DAT density with elements of the psychological/psychiatric evaluation (i.e. psychological/ psychiatric symptoms). For example, the researchers will examine the correlation of DAT density with sleep disturbance.

    Full Information

    First Posted
    July 11, 2017
    Last Updated
    October 25, 2019
    Sponsor
    St. Joseph's Hospital and Medical Center, Phoenix
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03216434
    Brief Title
    Striatal Dopamine Transporter Density in Post-Traumatic Stress Disorder (PTSD)
    Official Title
    Striatal Dopamine Transporter Density in Post-Traumatic Stress Disorder (PTSD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2020 (Anticipated)
    Primary Completion Date
    January 2023 (Anticipated)
    Study Completion Date
    May 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    St. Joseph's Hospital and Medical Center, Phoenix

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This research study is being done to try to find a way to accurately diagnose post-traumatic stress syndrome (PTSD) in combat veterans.Diagnostic biomarkers have made invaluable contributions to the diagnosis and treatment monitoring of many diseases and disorders. Unfortunately, PTSD currently lacks a reliable and compelling clinically-relevant biomarker. The absence of a viable biomarker impairs efficient and confident diagnosis of PTSD, with diminished effective care options often resulting.
    Detailed Description
    The possibility of developing PTSD exists when a person is exposed to death, threatened death, or actual or threatened serious injury either by direct exposure, witnessing the trauma, or learning that a close friend was exposed to this type of trauma. Rates of PTSD in military personnel returning from armed conflicts may be greater than 30%. The diagnosis of PTSD is based on a psychiatrist's or psychologist's assessment of the symptoms reported by the veteran and others, such as family or friends.The veteran with PTSD may struggle with thoughts and feelings that "don't make sense" or he or she believes are just not "warrior-like". The veteran eventually sees a mental health professional but may downplay the symptoms and fail to be correctly diagnosed. This places these men and women at risk for suicide. Dopamine is a substance found in our brains that has a role in regulating fear and stress as well as other emotional responses. There have been studies that have shown a protein in blood called dopamine transporter (DAT) moves dopamine from one place to another in our brain. Studies have shown that the level of DAT present has a role in PTSD. In this research, the researchers will evaluate the usefulness of a type of radioactive drug (DaTscan) which attaches to DAT and then allows the researchers to take pictures of the brain using a camera called a gamma camera. This will produce images called single photon emission computed tomography (SPECT). The researchers are looking for a difference in these pictures in those with PTSD and veterans without PTSD, and hope this can be used to help diagnose PTSD in the future.The brain MRI is done to make sure there is not anything abnormal in the structure of the brain that could interfere with the DaTScan pictures and to accurately locate specific regions of the brain where the DaTScan pictures are especially important. The MRI will also be used to look at natural nerve connections in the brain using functional MRI or fMRI. The researchers will use fMRI to look for possible connection differences in brains of people with PTSD and without PTSD. The DaTscan requires a drug, called a radiotracer given through an intravenous (IV) catheter. This drug is radioactive and a small amount of it will be absorbed by the thyroid gland, so Lugol's solution will be used to block uptake into the thyroid. The length of time to complete the entire DaTscan process is approximately 5 ½ hours. This includes time to receive the drug, then a 3 hour break followed by about 45 minutes to take the pictures. The tracer will collect in part of the brain and give off radiation (gamma rays). A gamma camera will produce pictures of the brain.The MRI process will take approximately 1 hour, including a questionnaire about metal or implants in the subject's body. Brain scanning will last for about 30 minutes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-traumatic Stress Disorder
    Keywords
    post-traumatic stress disorder, dopamine, biomarker

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PTSD Diagnosed
    Arm Type
    Experimental
    Arm Description
    Veterans exposed to combat and diagnosed with PTSD. MRI using DaTscan.
    Arm Title
    Designated Combat-Experienced Controls
    Arm Type
    Experimental
    Arm Description
    Veterans exposed to combat, but never diagnosed with PTSD. MRI using DaTscan.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    MRI using DaTscan
    Intervention Description
    A standard, non-contrast-enhanced structural/anatomic brain MRI will be performed. It will be used to exclude potential subjects and controls with significant and potentially confounding structural/anatomic findings. It will also be used as an "anatomic overlay" with the functional DaTscan image to aid in anatomic/physiologic correlation. At the same imaging session, a brief functional MRI (not requiring the subject to perform any tasks) will also be performed.
    Primary Outcome Measure Information:
    Title
    DaTscan intensity
    Description
    Visually recognizable increases in striatal DaTscan intensity in PTSD patients.
    Time Frame
    within 30 days of MRI
    Title
    Quantifiable differences
    Description
    Quantifiable differences in global and regional DAT density in PTSD patients and combat-experienced controls.
    Time Frame
    within 30 days of MRI
    Secondary Outcome Measure Information:
    Title
    Striatal correlations
    Description
    Global and regional striatal correlations of DAT density with elements of the psychological/psychiatric evaluation (i.e. psychological/ psychiatric symptoms). For example, the researchers will examine the correlation of DAT density with sleep disturbance.
    Time Frame
    within 60 days of entry into study

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    22 Years
    Maximum Age & Unit of Time
    39 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Males Diagnosed with PTSD (n=25) or designated combat-experienced controls (n=25) Exclusion Criteria: Head trauma resulting in loss of consciousness Co-morbid DSM IV Axis I psychiatric disorder hyper- or hypo-thyroidism, neurological motor deficits (e.g. Parkinsonism, tremor)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andrea Garcia, MBA
    Phone
    602-406-9769
    Email
    andrea.garcia2@dignityhealth.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frank V Schraml, MD
    Organizational Affiliation
    St. Joseph's Hospital and Medical Center, Phoenix
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Striatal Dopamine Transporter Density in Post-Traumatic Stress Disorder (PTSD)

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