[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591198":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":21,"responsibleParty":32,"collaborators":36,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":21,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":66,"whyStopped":21,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":21},{"fullName":5,"class":6},"New York State Psychiatric Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Methylphenidate","EXPERIMENTAL","Each subject will receive one oral dose of 60mg methylphenidate in between 2 PET scans with \\[11C\\]raclopride.",[13,14],"Drug: Methylphenidate (MPH)","Drug: [11C]raclopride",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Methylphenidate (MPH)","Each participate will receive one oral dose of 60mg methylphenidate.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"[11C]raclopride","This is the radiotracer that will be used along with methylphenidate to quantify dopamine transmission in this study. It is experimental and used for imaging purposes.",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"Ragy Girgis, MD","CONTACT","646-774-5553","ragy.girgis@nyspi.columbia.edu",{"type":33,"investigatorFullName":34,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Ragy Girgis","Professor of Clinical Psychiatry",[37,40,42],{"name":38,"class":39},"National Institute of Mental Health (NIMH)","NIH",{"name":41,"class":6},"Columbia University",{"name":43,"class":44},"Stony Brook Medicine","UNKNOWN","100591198","phase-1-a-multimodal-imaging-study-of-dopamine-in-early-psychosis-100591198",false,"NCT06977308","A Multimodal Imaging Study of Dopamine in Early Psychosis","MISDEP","Inclusion Criteria:\n\n1. Males or females between 18 and 30 years old\n2. Capacity to give informed consent\n3. Clinical High Risk (i.e., APSS, GRDS, BIPS)\n4. Antipsychotic free for 3 weeks before the PET scan\n5. Clinically stable enough for the study\n\nExclusion Criteria:\n\n1. Any substance use disorder, of any severity, within the previous month (before PET scan; not including nicotine or caffeine)\n2. Any current use of substance of abuse besides THC\u002Fmarijuana\u002Fcannabis\u002Fnicotine\u002Fcaffeine (on day of PET only)\n3. Daily tobacco use\n4. Pregnancy\n5. Lactation\n6. Presence of insulin-dependent diabetes\n7. IQ \\\u003C 70 (i.e., WTAR \\\u003C 6)\n8. Acute risk for suicide (i.e., score of 4-5 within the previous month or 6 within the previous 3 months on the CSSRS) or violence, or history of severe violent behavior that may be exacerbated by methylphenidate\n9. Presence of metallic objects in the body\n10. Lifetime exposure to radiation in the workplace (i.e., being badged for radiation exposure), or exposure to radiation in the context of research protocol within the previous year that exceeds annual limits\n11. More than one risk factor for coronary artery disease (e.g., smoking, hyperlipidemia, sedentary lifestyle)\n12. Hypertension\n13. Presence of clinically significant brain abnormalities. \\[For PET Scan Only\\]\n14. Previous adverse reaction to stimulants that would preclude receiving methylphenidate\n15. Presence or positive history of any cardiovascular disease, medical or neurological condition that would preclude methylphenidate administration or participation in this study\n16. A history of bipolar disorder Type 1, or any history of syndromal psychosis\n17. Lack of effective birth control","ALL","18 Years","30 Years",{"count":56,"type":57},115,"ESTIMATED","INTERVENTIONAL",[60],"PHASE1","The development of new treatments for psychosis, a psychiatric condition that is prevalent and highly disabling despite antipsychotic medications, has been limited, in part, by a lack of information from brain imaging studies during the period that leads to the development of psychotic symptoms. In this project the investigators will use Positron Emission Tomography (PET) and neuromelanin-sensitive magnetic resonance imaging (NM-MRI) to examine a brain chemical that is involved in schizophrenia called dopamine and where it first becomes abnormal. The investigators will use multimodal PET\u002FMR imaging (i.e., \\[11C\\]raclopride w\u002FMPH challenge and NM-MRI) in the same CHR patients. The investigators will recruit 115 clinical high risk individuals. All subjects will undergo \\[11C\\]raclopride w\u002Fmethylphenidate challenge and neuromelanin-MRI imaging along with clinical assessments. Patients will be followed every 3 months for two years or until conversion to psychosis, whichever comes first, to assess for conversion to psychosis and clinical outcomes.",[63],"Clinical High Risk for Psychosis (CHR)",[65],"clinical high risk for psychosis","NOT_YET_RECRUITING","2026-04-06",{"date":69,"type":70},"2026-04-08","ACTUAL",{"date":72,"type":57},"2026-06-01",{"date":74,"type":57},"2030-10-01",{"name":5,"class":6}]