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Neuropsychiatric SyndromesPhase 1NCT03705715

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

A Phase 1 study testing PET with radiotracer [11C]PBR-28 ( or [11C]ER176) and Affective challenge in people with Neuropsychiatric Syndromes, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Neuropsychiatric Syndromes
What is being tested?
PET with radiotracer [11C]PBR-28 ( or [11C]ER176) and Affective challenge
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
1 May 2017to Aug 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alan Prossin, MBBS contact

713-486-2836

alan.prossin@uth.tmc.edu

United States1 site, 1 recruiting

  • BBSB at UTHealth

    Houston, Texas, 77054

    alan R Prossin, MBBS, 713-486-2836, alan.prossin@uth.tmc.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

This study will explore whether brain microglial activation (which leads to an inflammatory response) is more extensive in individuals with clinical evidence of neuropsychiatric syndromes and whether the extent of microglial activation is proportional to the extent of neuropsychiatric symptoms.

More specifically, the hypothesis is that:

  1. Brain microglial activation is more substantial in the presence of neuropsychiatric illness, and the extent of brain microglial activation is proportional to severity of phenotypic presentation of neuropsychiatric illness (i.e. depression, cognitive impairment, fatigue, etc.) in a given patient.
  2. Specific brain regions where enhanced microglial activation is present underlie a portion of phenotypic variance in neuropsychiatric patients
  3. Combinations of neuropsychiatric phenotypes rather than specific differences in immune mechanisms underlie the contribution of central immune activation to a specific neuropsychiatric diagnosis.

The following measures will be obtained:

  1. microglial activation as quantified by PET using the radiotracer [11C]PBR-28 or [11C]ER176. ([11C]PBR-28 and [11C]ER176 specifically bind translocator protein (TSPO), which is associated with microglial activation and can thus serve as an in vivo biomarker of microglial activation and neuroinflammation. TSPO is also called the peripheral benzodiazepine receptor (PBR))
  2. dimension of specific neuropsychiatric symptoms (Hamilton Depression Rating Scale (HDRS), Montreal Cognitive Assessment (MoCA), Positive and Negative Affect Schedule (PANAS))
  3. presence/absence of a specific neuropsychiatric diagnosis (Dementing Illnesses, Traumatic Brain Injury, Major Depression, Bipolar Disorder, Pain Syndromes, Other Affective Disorders, etc.)

Using the above measures, correlations (and brain regional correlations) between the extent of microglial activation and the presence of a dimension of neuropsychiatric symptoms will be tested for. Following this, the presence of microglial activation (and brain regional microglial activation) 1) between healthy control volunteers and volunteers with neuropsychiatric syndromes and 2) between the various neuropsychiatric syndromes/diagnoses will be tested for.

Being tested
PET with radiotracer [11C]PBR-28 ( or [11C]ER176), Affective challenge
Keywords
Microglial activation, Immune activation, PET neuroimaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PET with radiotracer [11C]PBR-28 ( or [11C]ER176)Drug

    Also called [O-methyl-11C]N-acetyl-N-(2-methoxybenzyl)-2-phenoxy- 5-pyridinamine

    [11C]PBR-28 or [11C]ER176 will be injected into subjects' veins during PET scanning.

  • Affective challengeOther

    Also called biobehavioral challenges

    Affective challenge is the induction of, for example, mood or affective pain.

Study groups in NCT03705715
Study groupRoleWhat they receive
PET with radiotracer [11C]PBR-28 or [11C]ER176ExperimentalPET with radiotracer [11C]PBR-28 or [11C]ER176 will be performed. [11C]PBR-28 or [11C]ER176 will be injected into subjects' veins during PET scanning.
Receives: Drug: PET with radiotracer [11C]PBR-28 ( or [11C]ER176)
PET with radiotracer [11C]PBR-28 or [11C]ER176 and affective challengeExperimentalPET with radiotracer [11C]PBR-28 or [11C]ER176 will be performed. [11C]PBR-28 or [11C]ER176 will be injected into subjects' veins during PET scanning. Affective challenge (e.g. induction of mood, affective pain) will be presented to the patient during the PET scanning period.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (5)

  1. Affect as measured by the Hamilton Depression Rating Scale (HDRS)

    HDRS is a multiple item questionnaire used to provide an indication of depression. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression.

    Measured: within 1-2 hours before PETobtained during PET scanning (between 1:30 PM and 3 PM) at study baseline within a few days of study enrollment

  2. Mental Status as measured by the Montreal Cognitive Assessment (MoCA)

    The MoCA assesses several cognitive domains. The total possible score is 30 points with a score of 26 or more considered normal.

    Measured: within 1-2 hours before PETobtained during PET scanning (between 1:30 PM and 3 PM) at study baseline within a few days of study enrollment

  3. Affect as measured by the Positive and Negative Affect Schedule (PANAS)

    Positive Affect Score: Scores can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score: Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.

    Measured: within 1-2 hours before PETobtained during PET scanning (between 1:30 PM and 3 PM) at study baseline within a few days of study enrollment

  4. Affect as measured by the Positive and Negative Affect Schedule (PANAS)

    Positive Affect Score: Scores can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score: Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.

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

  5. Affect as measured by the Positive and Negative Affect Schedule (PANAS)

    Positive Affect Score: Scores can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score: Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.

    Measured: immediately following PET (3PM +/- 30 minutes)obtained during PET scanning (between 1:30 PM and 3 PM) at study baseline within a few days of study enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2018
  2. Study start1 May 2017
  3. Primary completionAug 2028 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03705715
Sponsor's protocol ID
HSC-MS-15-0744
Status last verified
Mar 2025
First submitted
10 Dec 2015
Last updated
19 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PET with radiotracer [11C]PBR-28 ( or [11C]ER176) and Affective challenge in people with Neuropsychiatric Syndromes, run by The University of Texas Health Science Center, Houston at 1 site in United States.

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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 19 Mar 2025. 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 United States. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alan Prossin, MBBS (713-486-2836, alan.prossin@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of TSPO expression as quantified by PET imaging to detect binding of the TSPO radiotracer [11C]PBR-28 (time frame: obtained during PET scanning (between 1:30 PM and 3 PM) at study baseline within a few days of study enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03705715.

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 19 Mar 2025.

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