Clinical trial
Identifying Correlates of Brain Microglial Activation in Neuropsychiatric Syndromes: A Dimensional Approach
Name
HSC-MS-15-0744
Description
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.
Trial arms
Trial start
2017-05-01
Estimated PCD
2028-08-01
Trial end
2028-08-01
Status
Recruiting
Phase
Early phase I
Treatment
PET with radiotracer [11C]PBR-28 ( or [11C]ER176)
\[11C\]PBR-28 or \[11C\]ER176 will be injected into subjects' veins during PET scanning.
Arms:
PET with radiotracer [11C]PBR-28 or [11C]ER176, PET with radiotracer [11C]PBR-28 or [11C]ER176 and affective challenge
Other names:
[O-methyl-11C]N-acetyl-N-(2-methoxybenzyl)-2-phenoxy- 5-pyridinamine
Affective challenge
Affective challenge is the induction of, for example, mood or affective pain.
Arms:
PET with radiotracer [11C]PBR-28 or [11C]ER176 and affective challenge
Other names:
biobehavioral challenges
Size
200
Primary endpoint
Level of TSPO expression as quantified by PET imaging to detect binding of the TSPO radiotracer [11C]PBR-28
obtained during PET scanning (between 1:30 PM and 3 PM) at study baseline within a few days of study enrollment
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2023-12-05
1 organization