NCT03705715 Identifying Correlates of Brain Microglial Activation in Neuropsychiatric Syndromes: a Dimensional Approach
| NCT ID | NCT03705715 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Neuropsychiatric Syndromes |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2017-05-01 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 200 participants in total. It began in 2017-05-01 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Alan Prossin, MBBS
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT03705715 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Neuropsychiatric Syndromes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03705715 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03705715 currently recruiting?
Yes, NCT03705715 is actively recruiting participants. Contact the research team at alan.prossin@uth.tmc.edu for enrollment information.
Where is the NCT03705715 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT03705715 clinical trial?
NCT03705715 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Alan Prossin, MBBS at The University of Texas Health Science Center, Houston. The trial plans to enroll 200 participants.