What this study is
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.
What's being tested
- PET with radiotracer [11C]PBR-28 ( or [11C]ER176)
Intervention · DRUG
[11C]PBR-28 or [11C]ER176 will be injected into subjects' veins during PET scanning.
- Affective challenge
Intervention · OTHER
Affective challenge is the induction of, for example, mood or affective pain.
Study details
- Sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Neuropsychiatric Syndromes
- Enrolling
- 200 people
- Starts
- 2017-05-01
- Est. completion
- 2028-08
- Design
- Open-label, non-randomized, parallel groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 80 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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)
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openBBSB at UTHealth
Houston, Texas, United States
- alan R Prossin, MBBS · Contact713-486-2836alan.prossin@uth.tmc.edu
Recruiting
Study team
Sponsor
The University of Texas Health Science Center, Houston
Study ID HSC-MS-15-0744
Principal investigator
Alan Prossin, MBBS
The University of Texas Health Science Center, Houston
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.