RecruitingPhase 1

Identifying Correlates of Brain Microglial Activation in Neuropsychiatric Syndromes: a Dimensional Approach

United States200 participantsStarted 2017-05-01

Plain-language summary

The purpose of this research is to determine whether there is more extensive inflammation in the brain of people with clinical evidence of neuropsychiatric syndromes, such as mood disorder, chronic pain syndrome, dementia, traumatic brain injury, or substance abuse. The research will also explore whether there is more inflammation in patients with more neuropsychiatric symptoms. Inflammation in the brain will identified by using Positron Emission Tomography (PET) with the radiotracer \[11C\]PBR-28 or \[11C\]ER176.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Must be between 18-80 years old * Males or females * Must be right handed * Must be able to sit unaccompanied for long periods of time with little body movement * Must be illicit drug free at time of scanning as appropriate (UDS negative), * Must be either healthy (without medical, neurological, psychiatric illness) or have a diagnosis of a neuropsychiatric syndrome (mood disorder, chronic pain syndrome, dementias, traumatic brain injury, substance/alcohol use disorder). * Healthy Control volunteers must be medication free (≥ 14 days) * Illicit drug free at time of scanning (verified by negative urine drug screen) Exclusion Criteria: * Must not be a smoker. * Females must not be pregnant or nursing. * Must not suffer from claustrophobia * Must not meet exclusion criteria for MRI scanning (i.e. non-fixed magnetisable objects) * Must not be PBR-28 low affinity binder (or using the \[11C\]ER176 study radiotracer) * Healthy control volunteers must not have on-going, chronic, or relapsing/remitting medical, psychiatric (absence of both DSM-IV Axis I and/or Axis II disorders), or neurological illness as determined by combination of history, medical record, and/or examination.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Level of TSPO expression as quantified by PET imaging to detect binding of the TSPO radiotracer [11C]PBR-28

Timeframe: obtained during PET scanning (between 1:30 PM and 3 PM) at study baseline within a few days of study enrollment

Trial details

NCT IDNCT03705715

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-08

Contact for this trial

Alan Prossin, MBBS

713-486-2836 alan.prossin@uth.tmc.edu

View on ClinicalTrials.gov More Neuropsychiatric Syndromes trials