[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT01246765":3,"trial-entities:NCT01246765":195,"trial-summary:NCT01246765":199},{"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":20,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":31,"interventions":34,"primary_outcomes":35,"secondary_outcomes":40,"sex":108,"minimum_age":109,"maximum_age":110,"healthy_volunteers":111,"eligibility_criteria":112,"std_ages":123,"locations":125,"central_contacts":143,"overall_officials":149,"references":152,"see_also_links":191},"NCT01246765","2008P-001861","National Pregnancy Registry for Psychiatric Medications","RECRUITING","2033-12","2025-10","2025-10-24","2008-11","Massachusetts General Hospital","OTHER",false,"The National Pregnancy Registry for Psychiatric Medications is dedicated to evaluating the safety of psychiatric medications such as antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics that many people take during pregnancy to treat a wide range of mood, anxiety, executive function, or psychiatric disorders. The goal of this Registry is to gather information on the safety of these medications during pregnancy, as current data is limited.","The overarching objectives of the National Pregnancy Registry for Psychiatric Medications are twofold: to assess risk for malformations among infants exposed to specific psychiatric medications and to assess neonatal outcomes associated with prenatal exposure to such medication. Specifically, the Registry will allow us to prospectively determine whether exposure to psychiatric medication is associated with any increased risk for major malformations above the baseline risk noted in the general population. This will be achieved by careful systematic documentation of medication exposure during pregnancy, as well as other relevant exposures often not included in small case series or published reviews of drug safety derived from large administrative databases.\n\nAlthough psychiatric medications are widely used by reproductive age women, reliable data regarding the reproductive safety of many of these compounds is limited. As a result, clinicians often lack sufficient evidence to evaluate the risks and benefits of using medications to treat psychiatric disorders during pregnancy. The National Pregnancy Registry for Psychiatric Medications is one of the first, and largest, hospital-based pregnancy registries which will systematically and prospectively monitor pregnancy outcomes after exposure to psychiatric medications, including antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics.\n\nPrimary Aim:\n\nTo prospectively evaluate rates of congenital malformations among infants exposed in-utero to psychiatric medications.\n\nSecondary Aims:\n\n1. To evaluate neonatal outcomes of infants with prenatal exposure to specific psychiatric medications alone or in combination with other psychotropics.\n2. To evaluate maternal health outcomes associated with use of psychiatric medications during pregnancy.\n3. To evaluate neurobehavioral development of children (1 month and older) with prenatal exposure to psychiatric medications.",[18,19],"Pregnant Women","Psychotropic Drugs",[21,22,23,24,25,26,27],"Pregnancy","Medication use during pregnancy","Psychiatric medications","ADHD","Atypical Antipsychotics","Antidepressants","Sedative Hypnotics","OBSERVATIONAL",null,[],{"count":32,"type":33},5000,"ESTIMATED",[],[36],{"measure":37,"description":38,"timeFrame":39},"Major Malformations in Infants","The primary outcome for this study is rates of major malformations among infants exposed in-utero to psychiatric medications. A major malformation is defined as a structural abnormality with surgical, medical, or cosmetic importance. Exclusions include (1) minor anomalies; (2) deformations; (3) physiologic features due to prematurity, such as undescended testes; (4) birthmarks; (5) genetic disorders and chromosomal abnormalities; and (6) any finding by prenatal sonography, such as absence of 1 kidney, or at surgery (or autopsy) that was not identified by an examining pediatrician. This data is collected through review of pediatric medical records through the first twelve months of infants' lives.","Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.",[41,45,49,53,56,59,62,65,68,72,75,78,81,84,87,90,94,97,101,104],{"measure":42,"description":43,"timeFrame":44},"Maternal Gestational Weight Gain","Maternal gestational weight gain is measured by the change in maternal weight from pre-pregnancy to weight at delivery, recorded in pounds.","Change from pre-pregnancy to delivery; assessed at 7 months' gestation and 8-12 weeks postpartum.",{"measure":46,"description":47,"timeFrame":48},"Live Birth","Did the pregnancy end in a live birth, assessed as a yes\u002Fno outcome.","Birth; assessed at 8-12 weeks postpartum.",{"measure":50,"description":51,"timeFrame":52},"Spontaneous Abortion (SAB)","Did a spontaneous abortion (SAB) occur during the pregnancy, assessed as a yes\u002Fno outcome.","Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum.",{"measure":54,"description":55,"timeFrame":52},"Intrauterine Fetal Demise (IUFD)","Did intrauterine fetal demise (IUFD) occur during the pregnancy, assessed as a yes\u002Fno outcome.",{"measure":57,"description":58,"timeFrame":48},"Gestational Age","The gestational age of the infant at birth, recorded in weeks and days.",{"measure":60,"description":61,"timeFrame":52},"Preterm Delivery","Was the baby born before 37 weeks gestational age, assessed as a yes\u002Fno outcome.",{"measure":63,"description":64,"timeFrame":48},"Birth Weight","Birth weight of the infant, recorded in grams or lbs and oz",{"measure":66,"description":67,"timeFrame":48},"Delivery Method","Was birth vaginal or by C-section; if C-section, emergent: yes\u002Fno",{"measure":69,"description":70,"timeFrame":71},"Gestational Diabetes","Gestational diabetes diagnosed during pregnancy, assessed as a yes\u002Fno outcome.","Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum.",{"measure":73,"description":74,"timeFrame":71},"Gestational Hypertension","Gestational hypertension diagnosed during pregnancy, assessed as a yes\u002Fno outcome.",{"measure":76,"description":77,"timeFrame":71},"Preeclampsia\u002FEclampsia","Pre-eclampsia or eclampsia diagnosed during pregnancy, assessed as a yes\u002Fno outcome.",{"measure":79,"description":80,"timeFrame":48},"Maternal Postpartum Hemorrhage","Did maternal postpartum hemorrhage occur, assessed as a yes\u002Fno outcome.",{"measure":82,"description":83,"timeFrame":48},"Apgar Scores","1-min and 5-min Apgar scores.",{"measure":85,"description":86,"timeFrame":39},"Neonatal Intensive Care Unit (NICU) admission","Was the infant admitted to the NICU, assessed as a yes\u002Fno outcome; if yes, number of days in NICU and reason for admission",{"measure":88,"description":89,"timeFrame":39},"Infant Death","Did the infant die before the age of one; assessed as a yes\u002Fno outcome.",{"measure":91,"description":92,"timeFrame":93},"Neonatal Extrapyramidal Symptoms","Did movement dysfunction occur in the infant (such as dystonia, akathisia, parkinsonism characteristic symptoms such as rigidity, bradykinesia, tremor, and tardive dyskinesia); assessed as a yes\u002Fno outcome.","Birth through 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.",{"measure":95,"description":96,"timeFrame":93},"Poor Neonatal Adaptation Syndrome (PNAS)","Did poor neonatal adaptation syndrome (PNAS) occur (including poor muscle tone, tremors, jitteriness, irritability, seizures, feeding difficulties, sleep disturbances, hypoglycemia, and respiratory distress); assessed as a yes\u002Fno outcome",{"measure":98,"description":99,"timeFrame":100},"Child Development Outcomes - Ages and Stages Questionnaire (ASQ-3)","Were there developmental concerns, as assessed by the Ages and Stages Questionnaire (ASQ-3).","Assessed at 9 months, year 3, and year 5.",{"measure":102,"description":103,"timeFrame":100},"Child Development Outcomes - Preschool Child Behavior Checklist (CBCL)","Were there developmental concerns, as assessed by the Preschool Child Behavior Checklist (CBCL).",{"measure":105,"description":106,"timeFrame":107},"Breastfeeding","Did breastfeeding occur, assessed as a yes\u002Fno outcome; if yes, duration of breastfeeding recorded in weeks.","Assessed at 8-12 weeks postpartum.","FEMALE","18 Years","45 Years",true,{"inclusion":113,"exclusion":118,"raw_text":122},[114,115,116,117],"Pregnant women","Age 18-45","Subjects will be willing to participate over the phone","Subjects will be able to provide informed consent",[119,120,121],"Women who have completed their pregnancy","Women who are planning to become pregnant","Women who are not taking any psychiatric medications and\u002For have no history of psychiatric illness","Inclusion Criteria:\n\n* Pregnant women\n* Age 18-45\n* Subjects will be willing to participate over the phone\n* Subjects will be able to provide informed consent\n\nExclusion Criteria:\n\n* Women who have completed their pregnancy\n* Women who are planning to become pregnant\n* Women who are not taking any psychiatric medications and\u002For have no history of psychiatric illness",[124],"ADULT",[126],{"facility":12,"status":7,"city":127,"state":128,"zip":129,"country":130,"contacts":131,"geoPoint":140},"Boston","Massachusetts","02114","United States",[132,137],{"name":133,"role":134,"phone":135,"email":136},"Bryn Rediger, BA","CONTACT","(617) 724-8020","admin@womensmentalhealth.org",{"name":138,"role":139},"Lee Cohen, MD","PRINCIPAL_INVESTIGATOR",{"lat":141,"lon":142},42.35843,-71.05977,[144,147],{"name":145,"role":134,"phone":135,"email":146},"Bryn Rediger","brediger@partners.org",{"name":138,"role":134,"phone":135,"email":148},"lcohen2@partners.org",[150],{"name":151,"affiliation":12,"role":139},"Lee S Cohen, MD",[153,157,161,164,167,170,173,176,179,182,185,188],{"pmid":154,"type":155,"citation":156},"26441156","BACKGROUND","Cohen LS, Viguera AC, McInerney KA, Freeman MP, Sosinsky AZ, Moustafa D, Marfurt SP, Kwiatkowski MA, Murphy SK, Farrell AM, Chitayat D, Hernandez-Diaz S. Reproductive Safety of Second-Generation Antipsychotics: Current Data From the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics. Am J Psychiatry. 2016 Mar 1;173(3):263-70. doi: 10.1176\u002Fappi.ajp.2015.15040506. Epub 2015 Oct 6.",{"pmid":158,"type":159,"citation":160},"38488388","DERIVED","Swetlik C, Cohen LS, Kobylski LA, Sojka ET, Killenberg PC, Freeman MP, Viguera AC. Effects of Prenatal Exposure to Second-Generation Antipsychotics on Development and Behavior Among Preschool-Aged Children: Preliminary Results From the National Pregnancy Registry for Psychiatric Medications. J Clin Psychiatry. 2024 Mar 13;85(1):23m14965. doi: 10.4088\u002FJCP.23m14965.",{"pmid":162,"type":159,"citation":163},"37235505","Szpunar MJ, Freeman MP, Kobylski LA, Rossa ET, Gaccione P, Chitayat D, Viguera AC, Cohen LS. Risk of Major Malformations in Infants After First-Trimester Exposure to Stimulants: Results From the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications. J Clin Psychopharmacol. 2023 Jul-Aug 01;43(4):326-332. doi: 10.1097\u002FJCP.0000000000001702. Epub 2023 May 29.",{"pmid":165,"type":159,"citation":166},"36825887","Viguera AC, Freeman MP, Kobylski LA, Rossa ET, Gaccione P, Chitayat D, Hernandez-Diaz S, Cohen LS. Risk of Major Malformations Following First-Trimester Exposure to Olanzapine: Preliminary Data From the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications. J Clin Psychopharmacol. 2023 Mar-Apr 01;43(2):106-112. doi: 10.1097\u002FJCP.0000000000001665.",{"pmid":168,"type":159,"citation":169},"36716275","Cohen LS, Church TR, Freeman MP, Gaccione P, Caplin PS, Kobylski LA, Arakelian M, Rossa ET, Chitayat D, Hernandez-Diaz S, Viguera AC. Reproductive Safety of Lurasidone and Quetiapine: Update from the National Pregnancy Registry for Psychiatric Medications. J Womens Health (Larchmt). 2023 Apr;32(4):452-462. doi: 10.1089\u002Fjwh.2022.0310. Epub 2023 Jan 30.",{"pmid":171,"type":159,"citation":172},"36602927","Viguera AC, McElheny SA, Caplin PS, Kobylski LA, Rossa ET, Young AV, Gaccione P, Goez-Mogollon L, Freeman MP, Cohen LS. Risk of Poor Neonatal Adaptation Syndrome Among Infants Exposed to Second-Generation Atypical Antipsychotics Compared to Antidepressants: Results From the National Pregnancy Registry for Psychiatric Medications. J Clin Psychiatry. 2023 Jan 4;84(1):22m14492. doi: 10.4088\u002FJCP.22m14492.",{"pmid":174,"type":159,"citation":175},"35909254","Szpunar MJ, Freeman MP, Kobylski LA, Caplin PS, Gaccione P, Viguera AC, Chitayat D, Hernandez-Diaz S, Cohen LS. Risk of major malformations in infants after first-trimester exposure to benzodiazepines: Results from the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications. Depress Anxiety. 2022 Dec;39(12):751-759. doi: 10.1002\u002Fda.23280. Epub 2022 Jul 31.",{"pmid":177,"type":159,"citation":178},"34352165","Viguera AC, Freeman MP, Goez-Mogollon L, Sosinsky AZ, McElheny SA, Church TR, Young AV, Caplin PS, Chitayat D, Hernandez-Diaz S, Cohen LS. Reproductive Safety of Second-Generation Antipsychotics: Updated Data From the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics. J Clin Psychiatry. 2021 Aug 3;82(4):20m13745. doi: 10.4088\u002FJCP.20m13745.",{"pmid":180,"type":159,"citation":181},"33710399","Freeman MP, Viguera AC, Goez-Mogollon L, Young AV, Caplin PS, McElheny SA, Church TR, Chitayat D, Hernandez-Diaz S, Cohen LS. Reproductive safety of aripiprazole: data from the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics. Arch Womens Ment Health. 2021 Aug;24(4):659-667. doi: 10.1007\u002Fs00737-021-01115-6. Epub 2021 Mar 12.",{"pmid":183,"type":159,"citation":184},"30111186","Cohen LS, Goez-Mogollon L, Sosinsky AZ, Savella GM, Viguera AC, Chitayat D, Hernandez-Diaz S, Freeman MP. Risk of Major Malformations in Infants Following First-Trimester Exposure to Quetiapine. Am J Psychiatry. 2018 Dec 1;175(12):1225-1231. doi: 10.1176\u002Fappi.ajp.2018.18010098. Epub 2018 Aug 16.",{"pmid":186,"type":159,"citation":187},"28810177","Panchaud A, Hernandez-Diaz S, Freeman MP, Viguera AC, MacDonald SC, Sosinsky AZ, Cohen LS. Use of atypical antipsychotics in pregnancy and maternal gestational diabetes. J Psychiatr Res. 2017 Dec;95:84-90. doi: 10.1016\u002Fj.jpsychires.2017.07.025. Epub 2017 Jul 29.",{"pmid":189,"type":159,"citation":190},"25939066","Cohen LS, Viguera AC, McInerney KA, Kwiatkowski MA, Murphy SK, Lemon EL, Hernandez-Diaz S. Establishment of the National Pregnancy Registry for Atypical Antipsychotics. J Clin Psychiatry. 2015 Jul;76(7):986-9. doi: 10.4088\u002FJCP.14br09418.",[192],{"label":193,"url":194},"National Pregnancy Registry for Atypical Antipsychotics Website","https:\u002F\u002Fwomensmentalhealth.org\u002Fresearch\u002Fpregnancyregistry\u002F",{"nct_id":4,"conditions":196,"biomarkers":198},[21,197],"Psychiatric Disorder",[],{"nct_id":4,"found":111,"summary":200,"prompt_version":209},{"design":201,"status":202,"heading":6,"summary":203,"follow_up":204,"word_count":205,"commitments":206,"compensation":207,"drugs_mentioned":208},"This is an observational study aiming to enroll 5000 pregnant women. It is not a treatment study but rather collects information about medication use during pregnancy.","completed","This registry is studying the safety of psychiatric medications like antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics when taken during pregnancy. The goal is to understand if these medications increase the risk of major birth defects (malformations) in babies. We are looking for pregnant women between 18 and 45 years old who are currently taking psychiatric medications. You cannot join if you have already given birth, are planning to become pregnant, or are not taking psychiatric medications. The study will look at whether babies exposed to these medications have more major malformations than babies in the general population, with information collected from birth up to one year of age.","Information about your baby's health will be collected from birth up to one year of age.",110,"You will be asked to participate over the phone and provide informed consent.","Not stated in the trial record.",[],"v2"]