Molecular Imaging of Brain Inflammation in Depressive Disorders

Completed

• Conditions: Depressive Disorder, Major; Positron-Emission Tomography

• Registration Number: NCT02983318
• Lead Sponsor: Lawson Health Research Institute

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-11-29
• Study First Submitted QC: 2016-12-02
• Study First Posted: 2016-12-06
• Study Start: 2017-08-28
• Status Verified: 2018-06
• Primary Completion: 2019-03-20
• Study Completion: 2019-12-31
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
inflammation-related excitotoxicity in the brain	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.

Trial Locations

Locations (1)

St Joseph's Hospital; 🇨🇦 London, Ontario, Canada