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NCT02019654 · ClinicalTrials.gov registry record
An Investigation of the Biological and Neuronal Mechanisms of Post Traumatic Stress Disorder, Depression and Post-Concussive Syndrome Onset Following a Traumatic Brain Injury
A clinical trial, sponsored by National Institute of Nursing Research (NINR).
- Completed
- Registry status
- 37
- Enrollment target
NCT02019654: Completed study, sponsored by National Institute of Nursing Research (NINR).
NCT02019654 is a clinical trial that has completed, run by National Institute of Nursing Research (NINR). The registered enrollment target is 37 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02019654 has completed, sponsored by National Institute of Nursing Research (NINR).
- COMPLETED
- Registry status
- 37 participants
- Enrollment target
Study Summary
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
Primary Outcome
Protein concentrations of inflammatory proteins (IL-1, IL-6, CRP), and lower concentrations of neuropeptides (IGF-1, BDNF, galanin, NPY) and higher concentrations of (SB100, GFAP) collected at the first appointment will predict the onset of PTSD, depression or PCS.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2015-02-03 |
| Est. Completion | 2020-07-27 |
What the finished NCT02019654 record still lists
NCT02019654 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 37 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02019654 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02019654 about?
NCT02019654 is a clinical study titled "An Investigation of the Biological and Neuronal Mechanisms of Post Traumatic Stress Disorder, Depression and Post-Concussive Syndrome Onset Following a Traumatic Brain Injury". 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 o...
What is the current status of trial NCT02019654?
This trial is currently completed. The enrollment target is 37 participants. The study started on 2015-02-03. Estimated completion is 2020-07-27.
Who is sponsoring clinical trial NCT02019654?
This trial is sponsored by National Institute of Nursing Research (NINR), which has 46 total clinical trials registered on ClinicalTrials.gov.
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