Molecular Imaging of Brain Inflammation in Depressive Disorders

Depressive Disorder, Major Clinical Trial

— DiME  

Official title:

Molecular Imaging of Brain Inflammation in Depressive Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983318
• Other study ID #: 100128
• Status: Completed
• Start date: August 28, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2018
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2019
• Est. primary completion date: March 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Encephalitis
• Inflammation
• Positron-Emission Tomography

Locations

Country	Name	City	State
Canada	St Joseph's Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammation-related excitotoxicity in the brain	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.	single time. Data collected at baseline with no follow up.