[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03705715":3,"trial-entities:NCT03705715":111,"trial-summary:NCT03705715":120},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":44,"secondary_outcomes":48,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":66,"eligibility_criteria":67,"std_ages":84,"locations":87,"central_contacts":103,"overall_officials":106,"references":109,"see_also_links":110},"NCT03705715","HSC-MS-15-0744","Identifying Correlates of Brain Microglial Activation in Neuropsychiatric Syndromes: a Dimensional Approach","RECRUITING","2028-08","2025-03","2025-03-19","2017-05-01","The University of Texas Health Science Center, Houston","OTHER",false,"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.","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.\n\nMore specifically, the hypothesis is that:\n\n1. 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.\n2. Specific brain regions where enhanced microglial activation is present underlie a portion of phenotypic variance in neuropsychiatric patients\n3. Combinations of neuropsychiatric phenotypes rather than specific differences in immune mechanisms underlie the contribution of central immune activation to a specific neuropsychiatric diagnosis.\n\nThe following measures will be obtained:\n\n1. 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))\n2. dimension of specific neuropsychiatric symptoms (Hamilton Depression Rating Scale (HDRS), Montreal Cognitive Assessment (MoCA), Positive and Negative Affect Schedule (PANAS))\n3. presence\u002Fabsence of a specific neuropsychiatric diagnosis (Dementing Illnesses, Traumatic Brain Injury, Major Depression, Bipolar Disorder, Pain Syndromes, Other Affective Disorders, etc.)\n\nUsing 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\u002Fdiagnoses will be tested for.",[18],"Neuropsychiatric Syndromes",[20,21,22],"Microglial activation","Immune activation","PET neuroimaging","INTERVENTIONAL","BASIC_SCIENCE",[26],"PHASE1",{"count":28,"type":29},200,"ESTIMATED",[31,39],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":37},"DRUG","PET with radiotracer [11C]PBR-28 ( or [11C]ER176)","\\[11C\\]PBR-28 or \\[11C\\]ER176 will be injected into subjects' veins during PET scanning.",[36],"PET with radiotracer [11C]PBR-28 or [11C]ER176",[38],"[O-methyl-11C]N-acetyl-N-(2-methoxybenzyl)-2-phenoxy- 5-pyridinamine",{"type":13,"name":40,"description":41,"otherNames":42},"Affective challenge","Affective challenge is the induction of, for example, mood or affective pain.",[43],"biobehavioral challenges",[45],{"measure":46,"timeFrame":47},"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",[49,53,56,59,61],{"measure":50,"description":51,"timeFrame":52},"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.","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",{"measure":54,"description":55,"timeFrame":52},"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.",{"measure":57,"description":58,"timeFrame":52},"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.",{"measure":57,"description":58,"timeFrame":60},"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",{"measure":57,"description":58,"timeFrame":62},"immediately following PET (3PM +\u002F- 30 minutes)obtained during PET scanning (between 1:30 PM and 3 PM) at study baseline within a few days of study enrollment","ALL","18 Years","80 Years",true,{"inclusion":68,"exclusion":77,"raw_text":83},[69,70,71,72,73,74,75,76],"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\u002Falcohol use disorder).","Healthy Control volunteers must be medication free (≥ 14 days)","Illicit drug free at time of scanning (verified by negative urine drug screen)",[78,79,80,81,82],"Must not be a smoker.","Females must not be pregnant or nursing.","Must not suffer from claustrophobia","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\u002Fremitting medical, psychiatric (absence of both DSM-IV Axis I and\u002For Axis II disorders), or neurological illness as determined by combination of history, medical record, and\u002For examination.","Inclusion Criteria:\n\n* Must be between 18-80 years old\n* Males or females\n* Must be right handed\n* Must be able to sit unaccompanied for long periods of time with little body movement\n* Must be illicit drug free at time of scanning as appropriate (UDS negative),\n* 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\u002Falcohol use disorder).\n* Healthy Control volunteers must be medication free (≥ 14 days)\n* Illicit drug free at time of scanning (verified by negative urine drug screen)\n\nExclusion Criteria:\n\n* Must not be a smoker.\n* Females must not be pregnant or nursing.\n* Must not suffer from claustrophobia\n* Must not meet exclusion criteria for MRI scanning (i.e. non-fixed magnetisable objects)\n* Must not be PBR-28 low affinity binder (or using the \\[11C\\]ER176 study radiotracer)\n* Healthy control volunteers must not have on-going, chronic, or relapsing\u002Fremitting medical, psychiatric (absence of both DSM-IV Axis I and\u002For Axis II disorders), or neurological illness as determined by combination of history, medical record, and\u002For examination.",[85,86],"ADULT","OLDER_ADULT",[88],{"facility":89,"status":7,"city":90,"state":91,"zip":92,"country":93,"contacts":94,"geoPoint":100},"BBSB at UTHealth","Houston","Texas","77054","United States",[95],{"name":96,"role":97,"phone":98,"email":99},"alan R Prossin, MBBS","CONTACT","713-486-2836","alan.prossin@uth.tmc.edu",{"lat":101,"lon":102},29.76328,-95.36327,[104],{"name":105,"role":97,"phone":98,"email":99},"Alan Prossin, MBBS",[107],{"name":105,"affiliation":12,"role":108},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":112,"biomarkers":119},[113,114,115,116,117,118],"Chronic pain syndrome","Dementia","Healthy","Mood Disorder","Substance use disorder","Traumatic Encephalopathy",[],{"nct_id":4,"found":66,"summary":121,"prompt_version":131},{"design":122,"status":123,"heading":124,"summary":125,"follow_up":126,"word_count":127,"commitments":128,"compensation":129,"drugs_mentioned":130},"This is an interventional study, meaning participants will receive a specific intervention. It plans to enroll 200 participants.","completed","Understanding Brain Inflammation in Neuropsychiatric Syndromes","This study aims to understand if there is more brain inflammation in people with neuropsychiatric syndromes like mood disorders, chronic pain, or dementia. Researchers will use a special imaging technique called PET (Positron Emission Tomography) with a tracer called [11C]PBR-28 or [11C]ER176. These tracers help detect inflammation in the brain. The study will also look at whether the amount of inflammation is related to the severity of symptoms. You might also undergo an \"affective challenge,\" which involves inducing certain moods or pain. The main goal is to measure the level of a protein called TSPO, which indicates brain inflammation, using these PET scans. This study is recruiting up to 200 participants, including healthy individuals and those with neuropsychiatric syndromes, aged 18 to 80.","The primary endpoint is measured during the PET scan at study baseline, within a few days of enrollment. No further follow-up is specified.",123,"You would receive an injection of [11C]PBR-28 or [11C]ER176 during a PET scan, which occurs between 1:30 PM and 3 PM. You would also undergo an affective challenge. You must be able to sit still for long periods.","Not stated in the trial record.",[40],"v2"]