Molecular Imaging of Brain Inflammation in Depressive Dis... | NCT02983318

Studies
Molecular Imaging of Brain Inflammation in Depressive Disorders

NCT02983318

Sponsor

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

Status

Completed

Last Update Posted

Apr 9, 2020Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Depressive Disorder, Major
Positron-Emission Tomography

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 28, 2017Actual

Primary Completion Date

Mar 20, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Nov 29, 2016

First Submission Date that Met QC Criteria

Dec 2, 2016

First Posted Date

Dec 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2020

Last Update Posted Date

Apr 9, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PET/MRI using 18[F]EPPA ligand		given experimental ligand FEPPA during MRI/PET scan to identify glutamate activity in the brain using FEPPA ligand

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

105 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lena Palaniyappan, MBBS/PhD	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Joseph's Hospital		London	Ontario	N6A 4V2	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

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Browse Branches

Not provided