{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T11:33:28Z","timestamp":1789472008632,"version":"build-2803163510"},"reference-count":33,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2015,6,1]],"date-time":"2015-06-01T00:00:00Z","timestamp":1433116800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2015,6,1]],"date-time":"2015-06-01T00:00:00Z","timestamp":1433116800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Child and Adolescent Psychopharmacology"],"published-print":{"date-parts":[[2015,6]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>The purpose of this study was to evaluate the safety and efficacy of asenapine in adolescents with schizophrenia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>\n                      In an 8 week, randomized, double-blind placebo-controlled trial, subjects (12\u201317 years of age) meeting\n                      <jats:italic toggle=\"yes\">Diagnostic and Statistical Manual of Mental Disorders,<\/jats:italic>\n                      4th ed., Text Revision (DSM-IV-TR) criteria for schizophrenia were randomized 1:1:1 to placebo, asenapine 2.5\u2009mg b.i.d., or asenapine 5\u2009mg b.i.d. Subjects who completed the 8 week acute study could participate in a 26 week flexible-dose asenapine-only open-label extension (OLE).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      A similar percentage of subjects completed treatment on day 56 (2.5\u2009mg b.i.d. (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      =98): 83%; 5\u2009mg b.i.d. [\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      =106]: 79%; placebo [\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      =102]: 79%). In the mixed model for repeated measures analysis of the primary end-point (with Hochberg correction for multiplicity), least squares (LS) mean differences between asenapine and placebo on the Positive and Negative Syndrome Scale (PANSS) total score at day 56 were not significant (\u22124.8 for 2.5\u2009mg b.i.d.,\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      =0.070; \u22125.6 for 5\u2009mg b.i.d.,\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      =0.064). Significant improvement in the Clinical Global Impressions-Severity score was observed in the 5\u2009mg b.i.d. group versus placebo on day 56 (LS mean \u22120.3,\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      =0.024). In the acute phase, \u22657% weight gain and the composite event of somnolence, sedation, and hypersomnia were more common in both asenapine groups than in the placebo group. Akathisia, fasting glucose elevation, and extrapyramidal syndrome were more common in the 5\u2009mg b.i.d. group than in the placebo group. There were no unexpected adverse events in the OLE, and PANSS total scores decreased by \u221216.1 points in the group previously treated with placebo (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      =62) and by \u221211.2 points in the continuous asenapine group (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      =131) from OLE baseline to week 26.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Although improvements in PANSS total score at day 56 of the acute phase were numerically greater for both asenapine 2.5 and 5\u2009mg b.i.d. than for placebo and were maintained in the OLE, the primary end-point did not achieve statistical significance in the acute phase. No new or unexpected safety concerns were detected during the acute phase or after an additional 26 weeks of asenapine treatment in the adolescent population with schizophrenia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trials Registry:<\/jats:title>\n                    <jats:p>\n                      NCT01190254 and NCT1190267 at\n                      <jats:uri xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/ClinicalTrials.gov\">ClinicalTrials.gov<\/jats:uri>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/cap.2015.0027","type":"journal-article","created":{"date-parts":[[2015,6,19]],"date-time":"2015-06-19T14:19:32Z","timestamp":1434723572000},"page":"384-396","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":53,"title":["Safety and Efficacy from an 8 Week Double-Blind Trial and a 26 Week Open-Label Extension of Asenapine in Adolescents with Schizophrenia"],"prefix":"10.1177","volume":"25","author":[{"given":"Robert L.","family":"Findling","sequence":"first","affiliation":[{"name":"The Johns Hopkins University\/Kennedy Krieger Institute"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronald P.","family":"Landbloom","sequence":"additional","affiliation":[{"name":"Merck"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary","family":"Mackle","sequence":"additional","affiliation":[{"name":"Merck"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wendi","family":"Pallozzi","sequence":"additional","affiliation":[{"name":"Merck"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabine","family":"Braat","sequence":"additional","affiliation":[{"name":"Merck","place":["The Netherlands"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carla","family":"Hundt","sequence":"additional","affiliation":[{"name":"Forest Research Institute"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marianne Z.","family":"Wamboldt","sequence":"additional","affiliation":[{"name":"University of Colorado\/Children's Hospital Colorado"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maju","family":"Mathews","sequence":"additional","affiliation":[{"name":"Forest Research Institute"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2015,6,1]]},"reference":[{"key":"e_1_3_3_2_1","unstructured":"American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders 4th ed. Text Revision. Washington DC: American Psychiatric Association; 2000."},{"key":"e_1_3_3_3_1","unstructured":"American Psychiatric Association: Practice Guideline for the Treatment of Patients with Schizophrenia 2nd ed. Arlington VA: American Psychiatric Association 2004."},{"key":"e_1_3_3_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/20.2.287"},{"key":"e_1_3_3_5_1","unstructured":"Centers for Disease Control and Prevention: A SAS Program for the 2000 CDC Growth Charts (ages 0 to <20\u2009y) 2014. Available at http:\/\/www.cdc.gov\/nccdphp\/dnpao\/growthcharts\/resources\/sas.htm. Accessed October7 2014."},{"key":"e_1_3_3_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eurpsy.2010.09.011"},{"key":"e_1_3_3_7_1","volume-title":"Poster presented at the 59th Annual Meeting of the American Academy of Child and Adolescent Psychiatry","author":"Dogterom P","unstructured":"Dogterom P, , Robert Riesenberg R, , Lesem M, , de Greef R, , Miltenburg A, , Landbloom R, , Troyer MD: Asenapine pharmacokinetics and tolerability in a pediatric population with a psychotic disorder: influence of dosing regimen. Poster presented at the 59th Annual Meeting of the American Academy of Child and Adolescent Psychiatry, October 23\u201328, 2012, San Francisco, CA."},{"key":"e_1_3_3_8_1","doi-asserted-by":"publisher","DOI":"10.1089\/cap.2012.0068"},{"key":"e_1_3_3_9_1","first-page":"583","article-title":"Double-blind maintenance safety and effectiveness findings from the Treatment of Early-Onset Schizophrenia Spectrum (TEOSS) study","volume":"49","author":"Findling RL","year":"2010","unstructured":"Findling RL, , Johnson JL, , McClellan J, , Frazier JA, , Vitiello B, , Hamer RM, , Lieberman JA, , Ritz L, , McNamara NK, , Lingler J, , Hlastala S, , Pierson L, , Puglia M, , Maloney AE, , Kaufman EM, , Noyes N, , Sikich L: Double-blind maintenance safety and effectiveness findings from the Treatment of Early-Onset Schizophrenia Spectrum (TEOSS) study. J Am Acad Child Adolesc Psychiatry, 49:583\u2013594; quiz 632, 2010.","journal-title":"J Am Acad Child Adolesc Psychiatry"},{"key":"e_1_3_3_10_1","doi-asserted-by":"publisher","DOI":"10.1089\/cap.2011.0092"},{"key":"e_1_3_3_11_1","doi-asserted-by":"crossref","first-page":"1432","DOI":"10.1176\/appi.ajp.2008.07061035","article-title":"A multiple-center, randomized, double-blind, placebo-controlled study of oral aripiprazole for treatment of adolescents with schizophrenia","volume":"165","author":"Findling RL","year":"2008","unstructured":"Findling RL, , Robb A, , Nyilas M, , Forbes RA, , Jin N, , Ivanova S, , Marcus R, , McQuade RD, , Iwamoto T, , Carson WH: A multiple-center, randomized, double-blind, placebo-controlled study of oral aripiprazole for treatment of adolescents with schizophrenia. Am J Psychiatry 2008, 165:1432\u20131441, 2008.","journal-title":"Am J Psychiatry 2008"},{"key":"e_1_3_3_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaac.2012.02.001"},{"key":"e_1_3_3_13_1","doi-asserted-by":"publisher","DOI":"10.1097\/chi.0b013e31807083fd"},{"key":"e_1_3_3_14_1","first-page":"157","volume-title":"ECDEU Assessment Manual for Psychopharmacology Rev. Ed","author":"Guy W","year":"1976","unstructured":"Guy W: The Clinical Global Impressions Scale. In: ECDEU Assessment Manual for Psychopharmacology Rev. Ed. Rockville, MD: National Institute of Mental Health; 1976; pp 157\u2013169."},{"key":"e_1_3_3_15_1","doi-asserted-by":"publisher","DOI":"10.1089\/cap.2008.0144"},{"key":"e_1_3_3_16_1","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.bp.107.046177"},{"key":"e_1_3_3_17_1","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.162.1.80"},{"key":"e_1_3_3_18_1","unstructured":"International Diabetes Federation: Criteria of metabolic syndrome in children and adolescents 2014. Available at http:\/\/www.idf.org\/metabolic-syndrome\/children\/criteria?language=fr. Accessed October8 2014."},{"key":"e_1_3_3_19_1","unstructured":"Introductory Guide for Standardized MedDRA Queries (SMQs) Version 15.1. MSSO-DI-6226-15.1.0 September 2012. Available at http:\/\/www.meddra.org\/sites\/default\/files\/guidance\/file\/SMQ_intguide_15_1_English_0.pdf Accessed October23 2014."},{"key":"e_1_3_3_20_1","unstructured":"Introductory Guide for Standardized MedDRA Queries (SMQs) Version 16.0. MSSO-DI-6226-16.0 March 2013. Available at http:\/\/www.meddra.org\/sites\/default\/files\/guidance\/file\/smq_intguide_16_0_english.pdf Accessed October23 2014."},{"key":"e_1_3_3_21_1","doi-asserted-by":"publisher","DOI":"10.1097\/JCP.0b013e3181d35d6b"},{"key":"e_1_3_3_22_1","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.10m06306"},{"key":"e_1_3_3_23_1","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/13.2.261"},{"key":"e_1_3_3_24_1","doi-asserted-by":"publisher","DOI":"10.1097\/CHI.0b013e3181900404"},{"key":"e_1_3_3_25_1","article-title":"Atypical antipsychotics for psychosis in adolescents","volume":"10","author":"Kumar A","year":"2013","unstructured":"Kumar A, , Datta SS, , Wright SD, , Furtado VA, , Russell PS: Atypical antipsychotics for psychosis in adolescents. Cochrane Database Syst Rev, 10:CD009582, 2013.","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_3_3_26_1","doi-asserted-by":"publisher","DOI":"10.2165\/11585350-000000000-00000"},{"key":"e_1_3_3_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaac.2013.02.008"},{"key":"e_1_3_3_28_1","doi-asserted-by":"publisher","DOI":"10.3371\/CSRP.5.4.6"},{"key":"e_1_3_3_29_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4780040211"},{"key":"e_1_3_3_30_1","first-page":"421","article-title":"The effects of novel and newly approved antipsychotics on serum prolactin levels: a comprehensive review","volume":"28","author":"Peuskens J","year":"2014","unstructured":"Peuskens J, , Pani L, , Detraux J, , De Hert M: The effects of novel and newly approved antipsychotics on serum prolactin levels: a comprehensive review. CNS Drugs, 28:421\u2013453, 2014.","journal-title":"CNS Drugs"},{"key":"e_1_3_3_31_1","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.v68n1004"},{"key":"e_1_3_3_32_1","unstructured":"SAPHRIS\u2122 (asenapine) US prescribing information. Forest Pharmaceuticals Inc Saint Louis MO. Merck Sharp & Dohme BV (used by Forest Pharmaceuticals Inc. under license) 2014."},{"key":"e_1_3_3_33_1","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.2008.08050756"},{"key":"e_1_3_3_34_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.biopsych.2011.06.021"}],"container-title":["Journal of Child and Adolescent Psychopharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1089\/cap.2015.0027","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/cap.2015.0027","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/cap.2015.0027","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T14:56:25Z","timestamp":1777388185000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1089\/cap.2015.0027"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,6]]},"references-count":33,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2015,6]]}},"alternative-id":["10.1089\/cap.2015.0027"],"URL":"https:\/\/doi.org\/10.1089\/cap.2015.0027","relation":{},"ISSN":["1044-5463","1557-8992"],"issn-type":[{"value":"1044-5463","type":"print"},{"value":"1557-8992","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,6]]}}}