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

NCT03216434 | Unknown DMC

• 1 other identifier: PHXB-17-0104-71-21
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post-traumatic Stress Disorder

Keywords

post-traumatic stress disorder; dopamine; biomarker

Outcome Measures

Primary Outcomes (2)

• DaTscan intensity

  Visually recognizable increases in striatal DaTscan intensity in PTSD patients.

  within 30 days of MRI

• Quantifiable differences

  Quantifiable differences in global and regional DAT density in PTSD patients and combat-experienced controls.

  within 30 days of MRI

Secondary Outcomes (1)

• Striatal correlations

  within 60 days of entry into study

Study Arms (2)

PTSD Diagnosed

EXPERIMENTAL

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

Diagnostic Test: MRI using DaTscan

Designated Combat-Experienced Controls

EXPERIMENTAL

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

Diagnostic Test: MRI using DaTscan

Interventions

MRI using DaTscan DIAGNOSTIC_TEST

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.

Designated Combat-Experienced Controls; PTSD Diagnosed

Eligibility Criteria

• Age: 22 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Frank V Schraml, MD

  St. Joseph's Hospital and Medical Center, Phoenix

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Garcia, MBA

CONTACT

602-406-9769; andrea.garcia2@dignityhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research clinician

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 13, 2017
• Study Start: January 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: May 1, 2023
• Last Updated: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share