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

Post-traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03216434
• Other study ID #: PHXB-17-0104-71-21
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2020
• Est. completion date: May 2023

Study information

• Verified date: October 2019
• Source: St. Joseph's Hospital and Medical Center, Phoenix
• Contact: Andrea Garcia, MBA
• Phone: 602-406-9769
• Email: andrea.garcia2[@]dignityhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 22 Years to 39 Years

Eligibility

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)

Related Conditions & MeSH terms

• Disease
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Diagnostic Test:
• MRI using DaTscan
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Hospital and Medical Center, Phoenix

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DaTscan intensity	Visually recognizable increases in striatal DaTscan intensity in PTSD patients.	within 30 days of MRI
Primary	Quantifiable differences	Quantifiable differences in global and regional DAT density in PTSD patients and combat-experienced controls.	within 30 days of MRI
Secondary	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.	within 60 days of entry into study