[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519930":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":40,"centralContacts":44,"locations":54,"responsibleParty":76,"collaborators":78,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":10,"enrollmentInfo":94,"targetDuration":10,"studyType":97,"phases":10,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":56,"whyStopped":10,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Antipsychotic medication",null,"Pregnant women with severe mental illness (diagnosis of bipolar disorder, primary psychotic disorder, or any history of psychiatric hospitalization) who are treated with any of the following medications during pregnancy: Quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone, lurasidone, haloperidol, or any other medication in the first- or second-generation antipsychotic class. All orally administered, with dosages titrated to clinical effect by the participant's primary psychiatrist.",[13],"Drug: Antipsychotics",{"label":15,"type":10,"description":16,"interventionNames":17},"Non-antipsychotic medication","Pregnant women with severe mental illness (diagnosis of bipolar disorder, primary psychotic disorder, or any history of psychiatric hospitalization) who are treated with any psychotropic medications during pregnancy other than those listed.",[18],"Drug: Non-antipsychotic medication",{"label":20,"type":10,"description":21,"interventionNames":22},"No medication","Pregnant women with severe mental illness (diagnosis of bipolar disorder, primary psychotic disorder, or any history of psychiatric hospitalization) who are not treated with any psychotropic medications during pregnancy.",[23],"Other: No Medication",[25,30,36],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"DRUG","Antipsychotics","Antipsychotic medications are widely prescribed for severe mental illness such as affective and non-affective psychosis, mood stabilization, and augmentation of unipolar depression.",[9],{"type":26,"name":15,"description":31,"armGroupLabels":32,"otherNames":33},"Psychotropic medications are typically prescribed to manage symptoms of anxiety, depression, psychological distress, and\u002For insomnia.",[15],[34,35],"Antidepressants","Benzodiazepines",{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":10},"No Medication","Non-psychotropic medications",[20],[41],{"name":42,"affiliation":5,"role":43},"Thalia Robakis, MD, PhD","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":10,"email":49},"Floriana Milazzo, MPH","CONTACT","(212) 659-1326","floriana.milazzo@mssm.edu",{"name":51,"role":47,"phone":52,"phoneExt":10,"email":53},"Veerle Bergink, MD, PhD","2126591326","veerle.bergink@mssm.edu",[55],{"facility":5,"status":56,"city":57,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"RECRUITING","New York","10029","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-74.00597,40.71427,{"lat":65,"lon":64},[68,72],{"name":69,"role":47,"phone":70,"phoneExt":10,"email":71},"Thalia Robakis","2126598893","thalia.robakis@mssm.edu",{"name":73,"role":47,"phone":74,"phoneExt":10,"email":75},"Luz Ospina","212-659-1326","luz.ospina@mssm.edu",{"type":43,"investigatorFullName":69,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Associate Professor",[79,81],{"name":80,"class":6},"Erasmus Medical Center",{"name":82,"class":83},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100519930","maternal-and-infant-antipsychotic-study-100519930",false,"NCT06049953","Maternal And Infant Antipsychotic Study","Developmental Effects of Antenatal Exposure to Antipsychotics","MAIA","Inclusion Criteria:\n\n* Pregnant\n* Severe mental illness, including:\n\n  * Psychotic disorder (affective and nonaffective)\n  * Bipolar disorder\n  * History of psychiatric hospitalization, regardless of diagnosis\n* Able to complete study interviews and measures in English, Dutch, or Spanish\n\nExclusion Criteria:\n\n* Active substance use disorder in pregnancy\n* Insufficiently high-functioning to provide full informed consent and\u002For participate in study procedures","FEMALE","18 Years",{"count":95,"type":96},74,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn about maternal psychiatric course and infant development in pregnant individuals with severe mental illness, comparing those treated with antipsychotics to those treated with other medications or without medication. The main questions it aims to answer are:\n\n1. Is risk of psychiatric relapse different among individuals who take antipsychotic medication, other medication, or no medication?\n2. Are pregnancy and neonatal health outcomes different among individuals who take antipsychotic medication, other medication, or no medication?\n3. Do infant behavior and neurodevelopment differ among babies who were exposed to antipsychotic medication, other medication, or no medication in utero? Participants will\n\n   * complete a psychiatric interview and questionnaires while pregnant;\n   * donate blood from the mother and from the umbilical cord at delivery\n   * have their babies participate in infant behavior evaluations and an EEG procedure.\n\nResearchers will compare these outcomes among individuals who were treated either with antipsychotic medication, with psychotropic medications of other classes, and with no medication, to see if psychiatric benefits for the mother and health outcomes for mother and child differ among these three types of treatment.",[27,100],"Pregnancy",[102,103,104,105,106],"antipsychotic","pregnancy","severe mental illness","neonatal adaptation syndrome","neurodevelopment","2026-06-18",{"date":109,"type":110},"2026-06-22","ACTUAL",{"date":112,"type":110},"2023-09-29",{"date":114,"type":96},"2028-01-01",{"name":5,"class":6},1]