NCT02019654

An Investigation of the Biological and Neuronal Mechanisms of Post Traumatic Stress Disorder, Depression and Post-Concussive Syndrome Onset Following a Traumatic Brain Injury

Completed Last updated 6 September 2022

What this trial tests

trial in Traumatic Brain Injury in 37 participants. Completed in 27 July 2020.

Timeline

3 February 2015

Primary endpoint
27 July 2020

27 July 2020

Quick facts

Lead sponsor	National Institute of Nursing Research (NINR)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	37
Start date	3 February 2015
Primary completion	27 July 2020
Estimated completion	27 July 2020
Sites	1 location across United States

Conditions studied

• Traumatic Brain Injury — all drugs for Traumatic Brain Injury →
• PTSD — all drugs for PTSD →
• Depression — all drugs for Depression →

Sponsor

National Institute of Nursing Research (NINR)

Who can join

Adults 18 to 65, any sex, with Traumatic Brain Injury or PTSD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: A traumatic brain injury (TBI) could mean a person is at high risk for other long-lasting problems. These problems could include post-traumatic stress disorder (PTSD), depression, and post-concussive syndrome (PCS). For example, about 700,000 Americans each year who have a TBI later go on to have PTSD also. Depression and PCS are also common in people who had a TBI. Some people will have these problems later. These problems can seriously interfere with a person s life. Some people will not have these problems at all. There are many reasons for this difference. Researchers think the main reason is that people have different genetic and environmental influences. Right now, we only have few kinds of treatments to prevent or treat these problems after a TBI. The few treatments we have often do not work well. It is important to understand what factors make a person at high risk for these problems after a TBI. This could allow researchers and doctors to help address these problems early. Addressing these problems earlier may help a person have better health in the long run.

Objectives:

* To study the biological changes that happen after mild to moderate TBI which could be linked to the onset of PTSD, depression, and post-concussive syndrome
* To study brain mechanisms that could explain risks for getting a psychiatric disorder after mild to moderate TBI. This will be done using a test called functional MRI (fMRI). This test takes images of the brain while a person is doing a simple task.

Eligibility:

* Men and women who are 18 to 65 years old.
* Had a mild to moderate TBI (including concussion) in the last month.

Design:

* 5 outpatient visits to the NIH Clinical Center over one year.
* The first visit is a screening visit to see if you can join the study. This visit must happen within 30 days of the TBI. The visit includes lab work (blood and urine), a history and physical exam done by a physician or nurse practitioner, and a psychiatric interview with a behavioral health nurse.
* Visits 2, 3, 4 and 5 happen at one, three, six and twelve months post-injury. At these visits participants may have some or all of the following tests: blood and saliva collection, urine collection, questionnaires and interviews to assess symptoms, a test to see your response to stress (called hydrocortisone challenge), and fMRI brain imaging.
* This study does not provide treatment.
* This study is not a substitute for seeing a primary care provider.
* This study should not replace any therapies you may be taking.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Galanin Receptors: G Protein-Dependent Signaling and Beyond
   Oláh J, Soltész-Katona E, Kaci H, Turu G, et al · · 2026