Brain Inflammation in Major Depressive Disorder Background
Completed
Conditions studied: Major Depression
In brief
Background: \- Studies have shown that inflammation plays an important role in depression. Brain inflammation may contribute to depression, and may make it more difficult to treat some kinds of depression with current therapies. Researchers want to use magnetic resonance imaging (MRI) and positron emission tomography (PET) scanning to study inflammation in the brain. To do so, they will use a contrast agent, which is a chemical that can show inflammation during an imaging study. Objectives: \- To see if people with major depressive disorder have increased inflammation in the brain. Eligibility: \- Individuals at least 18 years of age who have major depressive disorder. Design: * Participants will be screened with a physical exam and medical history. They will provide blood samples before the scanning sessions. * Participants will have a PET scan after the screening visit. They will have a dose of the contrast agent before the study. This scan will look for possible brain inflammation. * Participants will also have an MRI scan. This scan will take pictures of the brain for comparison studies. * Treatment will not be provided as part of this study.
Key facts
- Study ID
- NCT01851356
- Run by
- National Institute of Mental Health (NIMH)
- People needed
- 61
- Starts
- 2013-05-08
- Expected to finish
- 2018-03-22
- Last updated by the study team
- 2019-12-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- For healthy volunteers
- Any current Axis I diagnosis
- Clinically significant laboratory abnormalities other than CRP.
- Subjects with autoimmune disorders
- HIV positive
- Subjects with current infections
- Recent peripheral injury
- Smoking in the last 6 months, because smoking may cause a inflammatory responses
- Risk for MRI scan, such as a pacemaker or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, or shrapnel fragments. Welders and metal workers are also at risk for injury because of possible small metal fragments in the eye of which they may be unaware.
- History of neurologic illness or injury with the potential to affect study data interpretation.
- Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
- Inability to lie flat on camera bed for at least two hours.
- Pregnancy or breast feeding.
- Able to get pregnant but does not use birth control.
- Non binder to PBR28 determined with a blood test or genotyping
- Positive urine drug screen on the day of the scan
- Subjects receiving treatment likely to impact inflammation (e.g., chronic antinflammatory drug treatment), statins or corticosteroids
- Significant MRI abnormalities of the brain.
- History of seizures, other than in childhood and related to fever.
- A history of drug or alcohol abuse within 6 months or a history of alcohol or drug dependence (excepting nicotine) within 3 years (DSM-IV criteria)
- For patients
- Previous radiation exposure (X-rays, PET scans etc.) that, together with study procedures, would exceed NIH RSC research limits.
- Claustrophobia to a degree that the subject would feel uncomfortable in the MRI machine.
- Cannot lie on their back for at least two hours.
- Smoking in the last 6 months, because smoking may cause a inflammatory responses
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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