{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T10:09:53Z","timestamp":1788516593854,"version":"build-2803163510"},"reference-count":17,"publisher":"American Medical Association (AMA)","issue":"10","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Psychiatry"],"published-print":{"date-parts":[[2020,10,1]]},"DOI":"10.1001\/jamapsychiatry.2020.1596","type":"journal-article","created":{"date-parts":[[2020,7,1]],"date-time":"2020-07-01T15:02:39Z","timestamp":1593615759000},"page":"1064","source":"Crossref","is-referenced-by-count":20,"title":["Association of End Point Definition and Randomized Clinical Trial Duration in Clinical Trials of Schizophrenia Medications"],"prefix":"10.1001","volume":"77","author":[{"given":"Islam R.","family":"Younis","sequence":"first","affiliation":[{"name":"Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mathangi","family":"Gopalakrishnan","sequence":"additional","affiliation":[{"name":"Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland"},{"name":"Center for Translational Medicine, University of Maryland, Baltimore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitchell","family":"Mathis","sequence":"additional","affiliation":[{"name":"Division of Psychiatry Products, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mehul","family":"Mehta","sequence":"additional","affiliation":[{"name":"Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramana","family":"Uppoor","sequence":"additional","affiliation":[{"name":"Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hao","family":"Zhu","sequence":"additional","affiliation":[{"name":"Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tiffany","family":"Farchione","sequence":"additional","affiliation":[{"name":"Division of Psychiatry Products, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","reference":[{"issue":"4","key":"yoi200035r1","doi-asserted-by":"crossref","first-page":"368","DOI":"10.1001\/jama.2013.282034","article-title":"Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.","volume":"311","author":"Downing","year":"2014","journal-title":"JAMA"},{"issue":"9426","key":"yoi200035r2","doi-asserted-by":"crossref","first-page":"2063","DOI":"10.1016\/S0140-6736(04)16458-1","article-title":"Schizophrenia.","volume":"363","author":"Mueser","year":"2004","journal-title":"Lancet"},{"issue":"6","key":"yoi200035r3","doi-asserted-by":"crossref","first-page":"764","DOI":"10.4088\/JCP.15m10278","article-title":"The economic burden of schizophrenia in the United States in 2013.","volume":"77","author":"Cloutier","year":"2016","journal-title":"J Clin Psychiatry"},{"issue":"9","key":"yoi200035r4","doi-asserted-by":"crossref","first-page":"1122","DOI":"10.4088\/JCP.v66n0906","article-title":"The economic burden of schizophrenia in the United States in 2002.","volume":"66","author":"Wu","year":"2005","journal-title":"J Clin Psychiatry"},{"key":"yoi200035r5","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1016\/j.pneurobio.2016.07.004","article-title":"New drug developments in psychosis: Challenges, opportunities and strategies.","volume":"152","author":"Keshavan","year":"2017","journal-title":"Prog Neurobiol"},{"issue":"7","key":"yoi200035r6","doi-asserted-by":"crossref","first-page":"418","DOI":"10.1016\/S0924-9338(01)00600-9","article-title":"The scientific and ethical basis for placebo-controlled trials in depression and schizophrenia: an FDA perspective.","volume":"16","author":"Laughren","year":"2001","journal-title":"Eur Psychiatry"},{"issue":"4","key":"yoi200035r7","doi-asserted-by":"crossref","first-page":"429","DOI":"10.1038\/sj.mp.4002136","article-title":"How effective are second-generation antipsychotic drugs? a meta-analysis of placebo-controlled trials.","volume":"14","author":"Leucht","year":"2009","journal-title":"Mol Psychiatry"},{"issue":"3","key":"yoi200035r8","doi-asserted-by":"crossref","first-page":"504","DOI":"10.1093\/schbul\/sbn110","article-title":"What is causing the reduced drug-placebo difference in recent schizophrenia clinical trials and what can be done about it?","volume":"36","author":"Kemp","year":"2010","journal-title":"Schizophr Bull"},{"issue":"7376","key":"yoi200035r9","doi-asserted-by":"crossref","first-page":"161","DOI":"10.1038\/480161a","article-title":"Novartis to shut brain research facility.","volume":"480","author":"Abbott","year":"2011","journal-title":"Nature"},{"issue":"4","key":"yoi200035r11","doi-asserted-by":"crossref","first-page":"261","DOI":"10.2165\/11598460-000000000-00000","article-title":"Modelling and simulation of the Positive and Negative Syndrome Scale (PANSS) time course and dropout hazard in placebo arms of schizophrenia clinical trials.","volume":"51","author":"Pilla Reddy","year":"2012","journal-title":"Clin Pharmacokinet"},{"issue":"12","key":"yoi200035r12","doi-asserted-by":"crossref","first-page":"1228","DOI":"10.1001\/archpsyc.60.12.1228","article-title":"Delayed-onset hypothesis of antipsychotic action: a hypothesis tested and rejected.","volume":"60","author":"Agid","year":"2003","journal-title":"Arch Gen Psychiatry"},{"issue":"6","key":"yoi200035r13","doi-asserted-by":"crossref","first-page":"554","DOI":"10.1097\/01.jcp.0000246211.95905.8c","article-title":"Optimizing early prediction for antipsychotic response in schizophrenia.","volume":"26","author":"Chang","year":"2006","journal-title":"J Clin Psychopharmacol"},{"issue":"3","key":"yoi200035r14","doi-asserted-by":"crossref","first-page":"286","DOI":"10.1097\/JCP.0b013e3181dcb7c3","article-title":"Early onset of antipsychotic action in schizophrenia: evaluating the possibility of shorter acute efficacy trials.","volume":"30","author":"Kinon","year":"2010","journal-title":"J Clin Psychopharmacol"},{"issue":"1-3","key":"yoi200035r15","doi-asserted-by":"crossref","first-page":"312","DOI":"10.1016\/j.schres.2008.01.018","article-title":"Predicting antipsychotic drug response - replication and extension to six weeks in an international olanzapine study.","volume":"101","author":"Leucht","year":"2008","journal-title":"Schizophr Res"},{"key":"yoi200035r16","doi-asserted-by":"crossref","first-page":"178","DOI":"10.1186\/1471-244X-11-178","article-title":"Use of non-parametric item response theory to develop a shortened version of the Positive and Negative Syndrome Scale (PANSS).","volume":"11","author":"Khan","year":"2011","journal-title":"BMC Psychiatry"},{"key":"yoi200035r17","doi-asserted-by":"crossref","first-page":"66","DOI":"10.1186\/1471-244X-7-66","article-title":"Item response analysis of the Positive and Negative Syndrome Scale.","volume":"7","author":"Santor","year":"2007","journal-title":"BMC Psychiatry"},{"key":"yoi200035r10","unstructured":"CDISC. SDTM. Accessed May 26, 2020. https:\/\/www.cdisc.org\/standards\/foundational\/sdtm"}],"container-title":["JAMA Psychiatry"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamapsychiatry\/articlepdf\/2767296\/jamapsychiatry_younis_2020_oi_200035_1601309860.15052.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,10,7]],"date-time":"2020-10-07T15:18:04Z","timestamp":1602083884000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamapsychiatry\/fullarticle\/2767296"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,10,1]]},"references-count":17,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2020,10,1]]}},"URL":"https:\/\/doi.org\/10.1001\/jamapsychiatry.2020.1596","relation":{},"ISSN":["2168-622X"],"issn-type":[{"value":"2168-622X","type":"print"}],"subject":[],"published":{"date-parts":[[2020,10,1]]}}}