{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T12:18:56Z","timestamp":1793103536796,"version":"4.5.0"},"reference-count":14,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2011,12,7]],"date-time":"2011-12-07T00:00:00Z","timestamp":1323216000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100008272","name":"Novartis Pharmaceuticals Corporation","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100008272","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Human Psychopharmacology"],"published-print":{"date-parts":[[2012,1]]},"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>The efficacy and tolerability characteristics of an antipsychotic are difficult to determine from a single registration study. We thus conducted an analysis that assessed key efficacy and tolerability outcomes <jats:italic>post hoc<\/jats:italic> from four pooled short\u2010term (4\u20136\u2009weeks) phase III studies that evaluated iloperidone versus placebo in patients with schizophrenia or schizoaffective disorder.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patient\u2010level data were pooled from four prospective, randomized, double\u2010blind, placebo\u2010controlled and active\u2010controlled, multicenter trials of iloperidone in patients with schizophrenia or schizoaffective disorder aged 18\u201365\u2009years. Iloperidone 4\u20138, 10\u201316, and 20\u201324\u2009mg\/day (all dosed twice daily) were compared with placebo. Active controls used for assay sensitivity included risperidone 4\u20138\u2009mg\/day, haloperidol 15\u2009mg\/day, and ziprasidone 160\u2009mg\/day. Outcomes of interest were change from baseline to endpoint in the Brief Psychiatric Rating Scale (derived) (BPRSd), Positive and Negative Syndrome Scale (PANSS)\u2010total (PANSS\u2010T) score, and PANSS\u2010positive (PANSS\u2010P) and PANSS\u2010negative (PANSS\u2010N) subscale scores. An analysis of covariance (with treatment and study as factors, baseline as a covariate) was performed to compare changes between the iloperidone treatment groups versus placebo, on the basis of a last\u2010observation\u2010carried\u2010forward approach for the intent\u2010to\u2010treat (ITT) populations. Tolerability outcomes were obtained from spontaneously reported adverse events (AEs), and number needed to harm was calculated for each antipsychotic versus placebo for the total population.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The ITT population included both schizoaffective and schizophrenia patients (<jats:italic>N<\/jats:italic>\u2009=\u20092401): <jats:italic>n<\/jats:italic>\u2009=\u2009370, <jats:italic>n<\/jats:italic>\u2009=\u2009494, and <jats:italic>n<\/jats:italic>\u2009=\u2009424 for iloperidone 4\u20138, 10\u201316, and 20\u201324\u2009mg\/day, respectively; <jats:italic>n<\/jats:italic>\u2009=\u2009294 for risperidone; <jats:italic>n<\/jats:italic>\u2009=\u2009114 for haloperidol; <jats:italic>n<\/jats:italic>\u2009=\u2009144 for ziprasidone; and <jats:italic>n<\/jats:italic>\u2009=\u2009561 for placebo. Treatment with iloperidone 10\u201316\u2009mg\/day or 20\u201324\u2009mg\/day was associated with significantly improved BPRSd, PANSS\u2010T, PANSS\u2010P, and PANSS\u2010N scores versus treatment with placebo. When only patients with schizophrenia were included (<jats:italic>n<\/jats:italic>\u2009=\u20091941), the pattern of results was essentially unchanged. The active controls confirmed assay sensitivity. Across all iloperidone dose groups, the incidences of extrapyramidal disorders and akathisia were similar to those observed with placebo. AEs for which the frequency was greater for iloperidone than placebo and for which the 95% confidence interval for number needed to harm did not contain infinity were dizziness, dry mouth, somnolence, nasal congestion, fatigue, sedation, and tachycardia; in general, for these AEs, frequency was higher with higher doses, resulting in a lower number needed to harm.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Consistent with product labeling, iloperidone 10\u201316\u2009mg\/day or 20\u201324\u2009mg\/day demonstrated significant improvement over placebo on BPRSd and PANSS\u2010T scores, as well as on PANSS\u2010P and PANSS\u2010N subscale scores over 6\u2009weeks of treatment in patients with schizophrenia and in the ITT population, which includes patients with schizoaffective disorder. Iloperidone did not differ from placebo in terms of extrapyramidal disorders and akathisia. Copyright \u00a9 2011 John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/hup.1254","type":"journal-article","created":{"date-parts":[[2011,12,8]],"date-time":"2011-12-08T04:49:08Z","timestamp":1323319748000},"page":"24-32","source":"Crossref","is-referenced-by-count":15,"title":["Efficacy of iloperidone in the short\u2010term treatment of schizophrenia: a <i>post hoc<\/i> analysis of pooled patient data from four phase III, placebo\u2010 and active\u2010controlled trials"],"prefix":"10.1002","volume":"27","author":[{"given":"Leslie","family":"Citrome","sequence":"first","affiliation":[{"name":"New York Medical College  Valhalla New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiangyi","family":"Meng","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals Corporation  East Hanover New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marla","family":"Hochfeld","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals Corporation  East Hanover New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen M","family":"Stahl","sequence":"additional","affiliation":[{"name":"University of California San Diego  La Jolla California USA"},{"name":"University of Cambridge  Cambridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2011,12,7]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1742-1241.2009.02142.x"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.2174\/157488609789006985"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1742-1241.2010.02344.x"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1517\/14740338.2011.560114"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.08m04531"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.v66n1203"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.schres.2011.05.018"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1080\/10673220216279"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/JCP.0b013e318169d4ce"},{"key":"e_1_2_8_11_1","unstructured":"Novartis Pharmaceuticals Corporation.2011.Fanapt (iloperidone) Tablets. Revised 4\/2011.http:\/\/www.pharma.us.novartis.com\/product\/pi\/pdf\/fanapt.pdf(accessed 03 June 2011)."},{"key":"e_1_2_8_12_1","unstructured":"Pfizer.2010.Geodon (ziprasidone HCl) and Geodon (ziprasidone mesylate) for Injection. Revised 12\/2010.http:\/\/media.pfizer.com\/files\/products\/uspi_geodon.pdf(accessed 10 March 2011)."},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1097\/JCP.0b013e3181692787"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1755-5949.2011.00234.x"},{"key":"e_1_2_8_15_1","doi-asserted-by":"crossref","first-page":"267","DOI":"10.1017\/9780521182089","volume-title":"Iloperidone, Stahl's Essential Psychopharmacology Prescribers Guide","author":"Stahl SM","year":"2011"}],"container-title":["Human Psychopharmacology: Clinical and Experimental"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fhup.1254","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fhup.1254","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/hup.1254","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,16]],"date-time":"2023-10-16T05:04:42Z","timestamp":1697432682000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/hup.1254"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2011,12,7]]},"references-count":14,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2012,1]]}},"alternative-id":["10.1002\/hup.1254"],"URL":"https:\/\/doi.org\/10.1002\/hup.1254","archive":["Portico"],"relation":{},"ISSN":["0885-6222","1099-1077"],"issn-type":[{"value":"0885-6222","type":"print"},{"value":"1099-1077","type":"electronic"}],"subject":[],"published":{"date-parts":[[2011,12,7]]}}}