[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03995121":3,"trial-entities:NCT03995121":86,"trial-summary:NCT03995121":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":37,"secondary_outcomes":42,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":58,"locations":61,"central_contacts":78,"overall_officials":83,"references":84,"see_also_links":85},"NCT03995121","2000021592","SV2 PET Imaging With [11C]APP311","Synaptic Density in Psychiatric Disorders Using SV2A Receptor PET Imaging With [11C]APP311","RECRUITING","2026-12","2026-01","2026-01-28","2017-12-01","Yale University","OTHER",false,"The aim of this study is to evaluate a new SV2A tracer, \\[11C\\]APP311, in healthy aging and neuropsychiatric disorders including psychotic disorders and cannabis use disorders.","The overall goal of this protocol is to study synaptic density in two psychiatric disorders (namely schizophrenia and other psychotic disorders, and cannabis use disorder) with this exciting new PET tracer. Secondary outcomes will include electroencephalography (EEG). A battery of EEG paradigms assessing sensory, perceptual, and cognitive functions will also be administered. The primary dependent measures will be traditional event related potentials (ERPs; e.g. latency and amplitude) as well as time X frequency analysis (inter-trial coherence and spectral power).",[19,20,21],"Schizophrenia and Other Psychotic Disorders","Cannabis Use Disorder","Healthy",[],"OBSERVATIONAL",null,[],{"count":27,"type":28},250,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","[11C]APP311","It has been shown that radiotracer \\[11C\\]APP311 (aka \\[11C\\]UCB-J) displays high specificity and selectivity for the synaptic vesicle protein SV2A. Since this protein is expressed ubiquitously in active synapses, this tracer has the potential to be a general purpose tool for quantitative imaging of synaptic density.",[20,35,36],"Healthy Control","Schizophrenia and other psychotic disorders",[38],{"measure":39,"description":40,"timeFrame":41},"Synaptic density in psychiatric disorders using SV2A receptor PET Imaging with [11C]APP311","To compare synaptic vesicle protein 2A (SV2A) density in two groups of subjects with psychiatric disorders (namely 'schizophrenia and other psychotic disorders', and 'cannabis use disorder') to that in healthy controls using the PET radiotracer 11C-APP311","One test day (one time point).",[43],{"measure":44,"description":45,"timeFrame":41},"Correlation of Synaptic density with cognition and EEG","To correlate SV2A density with concurrent measures of information processing such as cognitive performance on a neuropsychiatric battery and electroencephalographic (EEG) measures","ALL","18 Years","85 Years",true,{"inclusion":51,"exclusion":54,"raw_text":57},[52,53],"Willing and able to give voluntary written informed consent","Male and Female subjects, age 18 to 65 years, inclusive",[55,56],"MRI metal exclusions and claustrophobia.","Education completed is less than 12 years","Inclusion Criteria:\n\n* Willing and able to give voluntary written informed consent\n* Male and Female subjects, age 18 to 65 years, inclusive\n\nExclusion Criteria:\n\n* MRI metal exclusions and claustrophobia.\n* Education completed is less than 12 years",[59,60],"ADULT","OLDER_ADULT",[62],{"facility":63,"status":8,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":75},"Conneticut Mental Health Center","New Haven","Connecticut","06519","United States",[69],{"name":70,"role":71,"phone":72,"phoneExt":73,"email":74},"Deepak C D'Souza, MD","CONTACT","203-932-5711","2594","deepak.dsouza@yale.edu",{"lat":76,"lon":77},41.30815,-72.92816,[79],{"name":80,"role":71,"phone":81,"email":82},"Angerlyk Frytz, MD","203-974-7822","angerlyk.frytz@yale.edu",[],[],[],{"nct_id":4,"conditions":87,"biomarkers":90},[20,21,88,89],"Psychosis","Schizophrenia",[],{"nct_id":4,"found":49,"summary":92,"prompt_version":102},{"design":93,"status":94,"heading":95,"summary":96,"follow_up":97,"word_count":98,"commitments":99,"compensation":100,"drugs_mentioned":101},"This is an observational study with a planned enrollment of 250 participants. It is not specified if it is randomized or blinded.","completed","Observational Study of [11C]APP311 for Synaptic Density in Psychiatric Disorders","This observational study is looking at how a special imaging agent, [11C]APP311, can help us understand synaptic density (the connections between brain cells) in people with schizophrenia, other psychotic disorders, and cannabis use disorder, as well as in healthy individuals. [11C]APP311 helps visualize a protein called SV2A, which is found in these brain connections. The main goal is to measure synaptic density using a PET scan (a type of imaging) with [11C]APP311. You might be able to join if you are between 18 and 65 years old, can give written consent, and do not have certain MRI restrictions or less than 12 years of education. The study aims to enroll 250 participants.","Synaptic density is measured at one time point on a single test day. No further follow-up is specified.",112,"You would have one test day for the PET imaging. Electroencephalography (EEG) and a battery of EEG tests will also be administered.","Not stated in the trial record.",[32],"v2"]