{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,7]],"date-time":"2026-08-07T16:13:18Z","timestamp":1786119198036,"version":"build-2736575974"},"reference-count":23,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T00:00:00Z","timestamp":1783036800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T00:00:00Z","timestamp":1783036800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100018529","name":"Alkermes","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100018529","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100003769","name":"Eisai","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003769","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100007132","name":"Otsuka Pharmaceutical","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100007132","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100015235","name":"Supernus Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015235","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100014605","name":"Sage Therapeutics","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100014605","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Bipolar Disorders"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Systematically collected pregnancy safety data for cariprazine have been lacking, despite growing use of this medication across psychiatric indications. The goal of this analysis was to determine the risk of major malformations among infants of mothers with psychiatric illness who used cariprazine during the first trimester of pregnancy compared to unexposed controls.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The National Pregnancy Registry for Psychiatric Medications (NPRPM) is a prospective pharmacovigilance program in which pregnant women with psychiatric diagnoses are enrolled during pregnancy and followed through the postpartum period. Labor and delivery and pediatric medical records are reviewed for evidence of major malformations followed by final adjudication by a dysmorphologist blinded to medication exposure. Infants with first\u2010trimester exposure to cariprazine were compared to controls not exposed to second\u2010generation antipsychotic medications.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      As of September 9, 2025,\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u20094,125 have enrolled in the study. Of those enrolled, 58 cariprazine\u2010exposed infants and 2,098 infants in the comparison group were eligible for inclusion in this analysis. There were no major malformations in the cariprazine\u2010exposed group (absolute risk 0.00%; 95% confidence interval, 0.00%\u20136.16%) compared to 32 infants with major malformations in the control group (1.53%; 1.05%\u20132.15%).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In this prospective cohort, 0 of 58 infants exposed to cariprazine during the first trimester had major malformations, compared with 32 of 2,098 (1.53%) unexposed infants. Although these data are preliminary and cannot rule out modest teratogenic effects, they are nonetheless important to provide to health care providers and the public, as cariprazine use has been rising among women of reproductive age.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bdi.70138","type":"journal-article","created":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T11:19:19Z","timestamp":1783077559000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Risk of Major Malformations Following First\u2010Trimester Exposure to Cariprazine: Preliminary Data From the\n                    <scp>MGH<\/scp>\n                    National Pregnancy Registry for Psychiatric Medications"],"prefix":"10.1111","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7074-705X","authenticated-orcid":false,"given":"Adele C.","family":"Viguera","sequence":"first","affiliation":[{"name":"Massachusetts General Hospital, Ammon\u2010Pinizzotto Center for Women's Mental Health  Boston Massachusetts USA"},{"name":"Cleveland Clinic Cleveland Clinic Neurological Institute  Cleveland Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marlene P.","family":"Freeman","sequence":"additional","affiliation":[{"name":"Massachusetts General Hospital, Ammon\u2010Pinizzotto Center for Women's Mental Health  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ella K.","family":"Slaby","sequence":"additional","affiliation":[{"name":"Massachusetts General Hospital, Ammon\u2010Pinizzotto Center for Women's Mental Health  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana M.","family":"Manuelian","sequence":"additional","affiliation":[{"name":"Massachusetts General Hospital, Ammon\u2010Pinizzotto Center for Women's Mental Health  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Gaccione","sequence":"additional","affiliation":[{"name":"Massachusetts General Hospital, Ammon\u2010Pinizzotto Center for Women's Mental Health  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1944-7294","authenticated-orcid":false,"given":"David","family":"Chitayat","sequence":"additional","affiliation":[{"name":"University of Toronto  Toronto Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonia","family":"Hern\u00e1ndez\u2010D\u00edaz","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Harvard T.H. Chan School of Public Health  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lee S.","family":"Cohen","sequence":"additional","affiliation":[{"name":"Massachusetts General Hospital, Ammon\u2010Pinizzotto Center for Women's Mental Health  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,3]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.12659\/MSM.945411"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0094788"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.2015.15040506"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.2018.18010098"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.20m13745"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00737\u2010021\u201001115\u20106"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcpt.12372"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1097\/JCP.0b013e318172b8d5"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.3390\/ph6101221"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.h2298"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1097\/JCP.0b013e318295fe12"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamapsychiatry.2016.1520"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamapsychiatry.2022.4109"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.4088\/jcp.v66n0406.21"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.3389\/fpsyt.2024.1421395"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00737\u2010004\u20100059\u20103"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.157.2.179"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.2007.06101639"},{"key":"e_1_2_10_20_1","unstructured":"US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Center for Biologics Evaluation and Research \u201cGuidance for Industry Establishing Pregnancy Exposure Registries \u201daccessed October 16 2025 https:\/\/www.fda.gov\/media\/75607\/download#:~:text=V.\u2010 WHEN%20SHOULD%20SUCH%20A%20REGISTRY%20BE%20ESTABLISHED%3F of%20successfully%20completing%20the%20registry."},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.14br09418"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.18ah38120"},{"key":"e_1_2_10_23_1","first-page":"1","article-title":"Update on Overall Prevalence of Major Birth Defects\u2014Atlanta, Georgia, 1978\u20102005","volume":"57","author":"Centers for Disease Control and Prevention (CDC)","year":"2008","journal-title":"MMWR. Morbidity and Mortality Weekly Report"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/bdr2.1156"}],"container-title":["Bipolar Disorders"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bdi.70138","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/bdi.70138","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bdi.70138","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,6]],"date-time":"2026-08-06T17:47:57Z","timestamp":1786038477000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/bdi.70138"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,3]]},"references-count":23,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,8]]}},"alternative-id":["10.1111\/bdi.70138"],"URL":"https:\/\/doi.org\/10.1111\/bdi.70138","archive":["Portico"],"relation":{},"ISSN":["1398-5647","1399-5618"],"issn-type":[{"value":"1398-5647","type":"print"},{"value":"1399-5618","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,3]]},"assertion":[{"value":"2026-01-08","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-08","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-07-03","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70138"}}