Clinical trial NCT02983318: Molecular Imaging of Brain Inflammation in Depressive Disorders
Official title: Molecular Imaging of Brain Inflammation in Depressive Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder, Major
Positron-Emission Tomography
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Able to pass MRI screening form (reviewed by a MRI technician)
* 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 practising effective form of birth control)
* Patient and healthy controls must not have an infection or an autoimmune disorder or persistent inflammation.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: inflammation-related excitotoxicity in the brain
timeFrame: single time. Data collected at baseline with no follow up.
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: St Joseph's Hospital
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Lena Palaniyappan, MBBS/PhD
role: PRINCIPAL_INVESTIGATOR
References: