Depressive Disorder, MajorDiMENCT02983318
Molecular Imaging of Brain Inflammation in Depressive Disorders
An observational study of Depressive Disorder, Major and Positron-Emission Tomography, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Major, Positron-Emission Tomography
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 28 Aug 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
- use of Investigational agents within last month
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: single time. Data collected at baseline with no follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start28 Aug 2017
- Primary completion20 Mar 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lena Palaniyappan, MBBS/PhD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983318
- Sponsor's protocol ID
- 100128
- Acronym
- DiME
- Status last verified
- Jun 2018
- First submitted
- 29 Nov 2016
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Imaging of Brain Inflammation in Depressive Disorders
- ClinicalTrials.gov ID
- NCT02983318
- Acronym / sponsor ID
- DiME / 100128
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
- use of Investigational agents within last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena Palaniyappan, MBBS/PhD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, Major and Positron-Emission Tomography, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammation-related excitotoxicity in the brain (time frame: single time. Data collected at baseline with no follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.