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OpenTrials
Completed

NCT Number: NCT02983318

Molecular Imaging of Brain Inflammation in Depressive Disorders

In a number of neuropsychiatric disorders such as depression, both brain inflammation and glutamate mediated excitotoxicity (cell death through over-activated stimulation) are suspected to play a key role. It is difficult, if not impossible, to determine the potential destructiveness of the inflammatory response seen in disease states by studying the brain's inflammatory cells (microglia) activity in isolation. The investigators are proposing to develop the means to concurrently study inflammatory response (i.e., microglial activity) and its potentially devastating consequence (i.e., glutamate excitotoxicity) across the entire brain in order to establish the importance of inflammation. In this study the investigators propose a phased clinical study whereby the early-phase involves the development of our capacity to study inflammation-mediated damage to brain cells, followed by a feasibility study in patients with clinical depression that tests whether concurrent inflammation and glutamate excess could be measured in key brain regions associated with a depressed mood state.

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Key information

Age range

19 year–105 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St Joseph's Hospital

London, Ontario, N6A 4V2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • screening form for MRI/PET is satisfactory after being reviewed by a radiologist
  • diagnosed with depression or healthy control participants with no present mental health disorder
  • Good general health with no diseases expected to interfere with the study
  • Subject is not pregnant, lactating, or of childbearing potential (must be practicing effective form of birth control)
  • Patient and healthy controls must not have an infection or an autoimmune disorder or persistent inflammation.

Exclusion criteria

  • Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
  • use of Investigational agents within last month

Treatment and study plan

Primary outcomes

  1. inflammation-related excitotoxicity in the brain

    Time frame: single time. Data collected at baseline with no follow up.

    Cross sectional MRI/PET scan will be used to identify inflammation related excitotoxicity in the brain in healthy individuals and those diagnosed with major depression.

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Acronym: DiME

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 6, 2016
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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