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
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
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
NCT ID
NCT03216434
First Posted
July 11, 2017
Last Updated
October 25, 2019
Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
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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