Brain Inflammation in Major Depressive Disorder Background

NCT01851356 | Completed

• 2 other identifiers: 13010013-M-0100
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depression

Keywords

PBR28; Depression; PET Imaging; Neuroinflammation

Outcome Measures

Primary Outcomes (1)

• Comparison of VT values obtained in MDD subject with those from healthy controls.

  single time point

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For healthy volunteers
• Age 18 or older
• No serious current medical condition
• Able to give written informed consent.
• No prior diagnosis of drug or alcohol dependence.
• For patients
• Age 18 or older
• Able to give written informed consent.
• Subjects will have met DSM-IV criteria for recurrent MDD in a current major depressive episode.
• No prior diagnosis of drug or alcohol dependence.

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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Cagnin A, Brooks DJ, Kennedy AM, Gunn RN, Myers R, Turkheimer FE, Jones T, Banati RB. In-vivo measurement of activated microglia in dementia. Lancet. 2001 Aug 11;358(9280):461-7. doi: 10.1016/S0140-6736(01)05625-2.

  PMID: 11513911 BACKGROUND

• Banati RB, Myers R, Kreutzberg GW. PK ('peripheral benzodiazepine')--binding sites in the CNS indicate early and discrete brain lesions: microautoradiographic detection of [3H]PK11195 binding to activated microglia. J Neurocytol. 1997 Feb;26(2):77-82. doi: 10.1023/a:1018567510105.

  PMID: 9181482 BACKGROUND

• Banati RB, Newcombe J, Gunn RN, Cagnin A, Turkheimer F, Heppner F, Price G, Wegner F, Giovannoni G, Miller DH, Perkin GD, Smith T, Hewson AK, Bydder G, Kreutzberg GW, Jones T, Cuzner ML, Myers R. The peripheral benzodiazepine binding site in the brain in multiple sclerosis: quantitative in vivo imaging of microglia as a measure of disease activity. Brain. 2000 Nov;123 ( Pt 11):2321-37. doi: 10.1093/brain/123.11.2321.

  PMID: 11050032 BACKGROUND

• Paul S, Gallagher E, Liow JS, Mabins S, Henry K, Zoghbi SS, Gunn RN, Kreisl WC, Richards EM, Zanotti-Fregonara P, Morse CL, Hong J, Kowalski A, Pike VW, Innis RB, Fujita M. Building a database for brain 18 kDa translocator protein imaged using [11C]PBR28 in healthy subjects. J Cereb Blood Flow Metab. 2019 Jun;39(6):1138-1147. doi: 10.1177/0271678X18771250. Epub 2018 May 11.

  PMID: 29749279 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert B Innis, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 10, 2013
• Study Start: May 8, 2013
• Primary Completion: July 27, 2017
• Study Completion: March 22, 2018
• Last Updated: December 16, 2019

Record last verified: 2018-03-22

Locations

US (1)